3D and 4D keepsake ultrasound studio marketing: what FDA says and how to describe a session

A 3D or 4D keepsake ultrasound studio sells something that looks like part of prenatal care and is not: a session to see the fetus and take home images, with no medical exam behind it. That gap is where the marketing risk sits. FDA has said in plain words that it discourages ultrasound for keepsake images, the equipment involved is a prescription device, and every line on the website that hints at reassurance, diagnosis or a health benefit makes the session sound like the thing it is not. This guide sets out what FDA has published, what follows for the way a studio describes itself, and how an obstetric practice can offer images from an exam it was going to do anyway.

Pregnancy photos, ultrasound images in birth stories and patient consent are covered in our guide to OB-GYN practice marketing, and the question of whether HIPAA applies to a business that does not bill health plans is covered in doula, midwife and birth center marketing, so neither is repeated here. Diagnostic imaging centers, which run medically ordered exams, are covered in imaging center marketing.

What FDA has said about keepsake ultrasound

FDA’s consumer update on fetal keepsake images describes fetal ultrasound imaging and Doppler fetal heartbeat monitors as prescription devices designed to be used by trained health care professionals. It says they are not intended for over-the-counter sale or use, and that FDA strongly discourages their use for creating fetal keepsake images and videos. It explains why: ultrasound can heat tissues slightly and in some cases can produce very small bubbles in some tissues (cavitation), the long-term effects of heating and cavitation are not known, and so scans should be done only when there is a medical need, based on a prescription, and performed by appropriately trained operators.

The same update says keepsake videos are controversial because there is no medical benefit gained from exposing the fetus to ultrasound, that FDA was aware of enterprises commercializing ultrasound by making them, and that in some cases the machine may be used for as long as an hour to get a video. It says that in creating keepsake videos there is no control on how long a single session will last, how many sessions will take place, or whether the systems will be operated properly. It also acknowledges that fetal imaging can promote bonding between parents and the developing fetus, and adds that such opportunities are routinely provided during prenatal care.

Two dating notes matter. The update says content current as of December 16, 2014, and as of our check on October 29, 2026, FDA no longer serves it at its original address; the last copy we could retrieve from a public web archive is from May 2023. FDA’s current Ultrasound Imaging page, content current as of September 19, 2024, carries the same position in shorter form: it says the use of ultrasound solely for non-medical purposes such as obtaining fetal keepsake videos has been discouraged, and that keepsake images or videos are reasonable if they are produced during a medically indicated exam and no additional exposure is required. When you cite FDA, cite the current page first and give the date.

The equipment is a prescription device

FDA classifies diagnostic ultrasound systems as Class II devices. Under 21 CFR 892.1560, an ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of tissue interfaces, and under 21 CFR 892.1550, an ultrasonic pulsed doppler imaging system combines continuous wave Doppler and pulsed echo technology to determine tissue characteristics such as depth or the velocity of blood or tissue motion.

Under 21 CFR 801.109, a prescription device is one that is not safe except under the supervision of a practitioner licensed by law to direct its use, and its label carries the statement Rx only or a caution that federal law restricts the device to sale by or on the order of a practitioner. FDA’s keepsake update calls fetal ultrasound and Doppler heartbeat monitors prescription devices. The marketing point is narrow but real: a studio’s website should never describe its scanner as approved for keepsake use, consumer use or entertainment, because FDA has said the opposite. Describe the machine, if at all, by what it is, not by what you wish its labeling said.

Whether a studio may operate at all, who may run the scanner, whether a practitioner’s order is required and what supervision applies are questions of state law. FDA’s Ultrasound Imaging page says individual states regulate the use of diagnostic ultrasound through recommendations and requirements for personnel qualifications, quality assurance and quality control programs, and facility accreditation. Get a written opinion from a health care attorney in your state on your exact model before you advertise it, and keep it on file.

A studio session is not a medical exam

The sentence a keepsake studio’s website cannot do without is the one that says what the session is not. A clear version: our sessions are not medical exams. We do not diagnose, measure, check the health of your baby or your pregnancy, or replace any scan your prenatal care provider orders. Keep seeing your prenatal provider and bring any question about your pregnancy to them. Put it on the home page, on every package page, on the booking page and in the confirmation message, not only in the terms.

Then make sure nothing else on the site contradicts it. Words and features that imply a medical exam include:

• Wellness check, reassurance scan, health check or peace of mind scan.
• Measurements, growth estimates, weight estimates, position checks or heartbeat checks offered as part of a package.
• Staff described with clinical job titles that the studio’s state law reserves to licensed or credentialed people, when the person doing the scan does not hold that license or credential.
• Medical imagery or wording such as exam room, patient or diagnostic quality in place of studio, client and session.
• Offers aimed at early pregnancy that suggest confirming the pregnancy or checking on it between prenatal visits.

Section 5 of the FTC Act, 15 U.S.C. 45, prohibits deceptive acts or practices, and section 12, 15 U.S.C. 52, makes it unlawful to disseminate a false advertisement likely to induce the purchase of devices or services. The FTC Health Products Compliance Guidance says advertisers are responsible for every claim a reasonable consumer would take from the ad as a whole, including implied claims, and that health benefit claims need competent and reliable scientific evidence. A session sold as reassurance implies that the client will learn something about the health of the pregnancy. If the session is not a medical exam, that implied claim is false.

If staff see something during a session that worries them, the policy belongs in writing before the first booking: what staff say, what they do not say, and how they refer the client to their own prenatal provider. Write the website copy from that policy, for example: if you have any concern about your pregnancy, contact your prenatal care provider. Do not advertise that staff will tell clients if anything looks wrong; that is a diagnostic promise.

Claims to leave out

Keepsake marketing pulls toward a small set of promises. Each one has a problem.

Safety claims. FDA’s Ultrasound Imaging page says ultrasound is generally considered safe when used prudently by appropriately trained health care providers, and in the same paragraph says ultrasound energy can heat tissues slightly or produce cavitation, that the long-term consequences are still unknown, and that use solely for non-medical purposes has been discouraged. It also says the risks may increase with unnecessary prolonged exposure or when untrained users operate the device. A studio that writes completely safe, no radiation so no risk, or safe for your baby is quoting half of FDA’s sentence and leaving out the half aimed at its own business. Leave safety claims off the site.

Bonding outcomes. FDA’s update acknowledges that fetal imaging can promote bonding, then adds that such opportunities are routinely provided during prenatal care. A claim that a session will strengthen the parent’s bond, reduce anxiety or improve the pregnancy is a health or psychological benefit claim, and the FTC guidance requires evidence for it. Describe what the client gets, such as the images and the time in the studio, not what the session will do for them.

Sex of the fetus. A guaranteed or accurate gender reveal claim is a promise about a determination from an image. Because the session is not a medical exam, the studio should not advertise it as a way to learn the sex of the fetus with any stated accuracy, and should not run promotions that make the reveal the product. If a client asks, the answer is the same as for any question about the pregnancy: their prenatal provider can tell them.

Image results. A promise of a clear face every time, or a free rescan if you do not see the face, ties the product to how long and how often the fetus is scanned. FDA named uncontrolled session length and number of sessions as its concern. Sell a defined package with a fixed maximum time, and do not advertise extra scanning time or repeat sessions as a remedy for poor images.

Before and after or sample images. Sample images on the site should be ones the studio actually produced, with the client’s written permission, and should not be presented as typical unless they are. Under 16 CFR 255.2(b), an advertisement that conveys an endorser’s experience with a key attribute is likely to be read as showing what consumers will generally achieve, so unless the advertiser can substantiate that the experience is representative, the ad should clearly and conspicuously disclose the generally expected performance. Our testimonials and before-and-after photos guide covers the consent and disclosure steps.

Heartbeat recordings and home Doppler devices

FDA’s keepsake update has a second half: Doppler ultrasound heartbeat monitors, used to listen to the heartbeat of the fetus, are legally marketed as prescription devices and should only be used by, or under the supervision of, a health care professional. FDA’s Ultrasound Imaging page adds that use by untrained persons could expose the fetus to prolonged and unsafe energy levels, or could provide information that is interpreted incorrectly by the user.

Two marketing consequences follow. A studio should not sell, rent or promote home Doppler devices to clients. And heartbeat recordings offered as an add-on come from the same scanning that FDA discourages for keepsake purposes, so they should be described as a recording, never as a heartbeat check, and should not add scanning time beyond the package.

Keepsake images from a medically indicated exam

For an obstetric practice, FDA’s current page points to a different route. It says keepsake images or videos are reasonable if they are produced during a medically indicated exam and no additional exposure is required. A practice that already performs the ultrasound its provider ordered can tell patients that, where the exam allows, they may receive images from it, without extending the exam to get them.

Market that carefully as well. Say that images are offered when the exam allows, that the exam is done for medical reasons, and that the sonographer or physician will not extend the scan to get a better picture. Do not sell upgraded images or longer scans as a paid add-on to a medical exam, and do not use a 3D or 4D image in an ad to suggest the exam is a keepsake session. Patient consent for any image used in marketing follows the steps in our OB-GYN guide.

A practice that cares for high-risk pregnancies has its own rules for ultrasound and prenatal screening pages, which our guide to maternal-fetal medicine practice marketing covers.

Local search and ads

A studio’s business profile and ads carry the same claims as its website, in fewer words. Pick a business category and description that match a keepsake imaging studio, not a medical clinic, and repeat the not a medical exam line in the description. Ad text should name the package and the images, not reassurance or health. Reviews that praise a reassurance or a diagnosis should not be quoted in ads or on the site, because quoting them adopts the claim. Our patient reviews guide covers asking for reviews and replying to them.

Illustration: a studio rewrites its site

Illustration: a keepsake studio’s old site leads with a banner reading peace of mind scans from 6 weeks, lists a heartbeat check and growth estimate in its starter package, promises a free rescan if the face is not visible, and calls the room an exam room. A rebuilt site leads with the images and the studio experience, puts the not a medical exam statement above the fold and on every package, drops the early pregnancy offer, the heartbeat check and the growth estimate, and sells packages with a fixed maximum time and no rescan promise. The safety section is gone, and in its place is a short note that FDA discourages ultrasound for keepsake purposes, with a link to FDA’s Ultrasound Imaging page, and a line telling clients to keep seeing their prenatal provider.

Illustration: an obstetric practice adds a short section to its prenatal care page saying that patients may receive images from an ultrasound their provider orders, when the exam allows, and that the exam is not extended to get them. There is no price for images and no 3D upgrade.

Checklist

• Written opinion from a health care attorney in your state on whether and how your studio may operate, who may scan and under whose order.
• The not a medical exam statement on the home page, each package page, the booking page and the confirmation message.
• No wellness, reassurance, health check, measurement, growth, position or heartbeat check wording.
• No safety claims; FDA’s discouragement of keepsake ultrasound cited and linked with its date where you mention FDA at all.
• No bonding, anxiety or pregnancy outcome claims (15 U.S.C. 45, 52; FTC Health Products Compliance Guidance).
• No accuracy claims or promotions for learning the sex of the fetus.
• Fixed maximum session time; no extra scanning time or free rescans advertised.
• No sale or promotion of home Doppler devices; heartbeat recordings described as recordings only.
• Sample images are your own, used with written permission, and meet 16 CFR 255.2(b).
• A written policy for concerns seen during a session, with referral to the client’s prenatal provider.
• Business profile category, description and ad text match a keepsake studio, not a clinic.

How we help

We build websites, local search, Google Ads and AI front desk tools for independent practices and health businesses. For a keepsake studio, we can rebuild a website around the images and the experience, with the not a medical exam statement where clients will see it, packages written without health claims and FDA’s position cited with dates. For an obstetric practice, we can write prenatal care pages that explain when images from an ordered exam are available without turning the exam into a product. Our AI front desk is built with HIPAA in mind and can answer questions about packages, hours and booking from a list you approve, and send any question about a pregnancy to a reply that points the client to their prenatal provider. We confirm in writing what a BAA covers before any patient information flows through a tool, and if it is not covered, we do not route patient information through it. We do not sell lead lists and do not pay for referrals. For the wider set of rules we follow, see our healthcare marketing rules hub.

Sources

• FDA consumer update: Avoid Fetal Keepsake Images, Heartbeat Monitors (content current as of December 16, 2014; archived copy of May 20, 2023)
• FDA: Ultrasound Imaging (content current as of September 19, 2024)
• 21 CFR 801.109: Prescription devices
• 21 CFR 892.1550: Ultrasonic pulsed doppler imaging system
• 21 CFR 892.1560: Ultrasonic pulsed echo imaging system
• 15 U.S.C. 45: Unfair methods of competition unlawful; prevention by Commission
• 15 U.S.C. 52: Dissemination of false advertisements (FTC Act section 12)
• FTC: Health Products Compliance Guidance (December 2022)
• 16 CFR 255.2: Consumer endorsements

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