All apps · Imaging & AI diagnostics

Certified imaging apps and AI diagnostic tools

19 imaging and AI diagnostic apps and devices, each checked against the FDA register, EUDAMED and the German DiGA directory. Last checked 18 October 2026.

This area is mostly for professionals: handheld ultrasound probes that run on a phone or tablet, AI that reads X-rays, dental images and brain scans, and imaging viewers. Almost all tools here hold an FDA 510(k) clearance.

Below you find every imaging and AI diagnostic tool we track, grouped by what we could verify in the official registers.

In the US: FDA verified (16)

Authorised by the FDA (510(k), De Novo or PMA), newest decisions first.

• Mmdprostate mediaire GmbH · 510(k) 2026, CE IIb
• RRelu Cloud Relu B.V. · 510(k) 2026, CE IIa
• ResolutionMD ResolutionMD, Inc. (formerly Calgary Scientific) · 510(k) 2026, CE IIa
• PPhilips Lumify Ultrasound App Philips Ultrasound · 510(k) 2025, CE IIa
• VVideaHealth VideaHealth, Inc. · 510(k) 2025
• CCapsoCam Plus CapsoVision, Inc. · 510(k) 2024
• BBoneView FDA Gleamer · 510(k) 2023, CE IIa
• Butterfly iQ Butterfly Network, Inc. · 510(k) 2023, CE IIa
• Clarius Ultrasound App Clarius Mobile Health Corp. · 510(k) 2023, CE IIa
• DDenti.AI Denti.AI Technology, Inc. · 510(k) 2023
• AATUSA Isono Health, Inc. · 510(k) 2022
• SONON Ultrasound Healcerion Co., Ltd. · 510(k) 2022, CE IIa
• CCercare Medical Neurosuite Cercare Medical A/S · 510(k) 2021, CE IIb
• IImmersiveTouch ImmersiveTouch, Inc. · 510(k) 2021
• IIntelliSpace Portal Platform Philips Medical Systems · 510(k) 2016
• Aaycan mobile Aycan Digitalsysteme GmbH · 510(k) 2012, CE IIa

In the EU: CE class IIa or higher (2)

Found in EUDAMED as class IIa or higher. We show whether a notified body certificate is visible there.

• Mmdbrain mediaire GmbH · CE IIb, certificate not visible in EUDAMED
• PPACSonWEB PACSonWEB · CE IIa, notified body certificate

Watchlist (1)

These products are presented as certified, by their maker or in earlier directories, but we found no matching record in the official register, or they are no longer supported by their maker. Some are registered and listed with the FDA as exempt devices, which is legal but is not a clearance.

• TThe Grin App and Grin Score Grin Technologies · no matching record

The trap to avoid

AI tools are cleared for a specific version, image type and intended user. Check that the version you buy matches the cleared one, and that the indication covers your use. A US clearance also does not cover use in Europe; ask for the CE certificate.

Questions

Which handheld ultrasound apps are FDA cleared?

In our directory: Butterfly iQ, Clarius Ultrasound App, Philips Lumify and SONON Ultrasound, all with 510(k) clearances.

Is AI for dental X-rays cleared?

Yes. VideaHealth (2025) and Denti.AI (2023) hold 510(k) clearances in our directory.

Are AI imaging tools certified in Europe?

Some are. In our directory, mdbrain carries CE class IIb and PACSonWEB CE class IIa. For others, ask the maker for the CE certificate and the notified body number.

Certification status changes. Always confirm in the official register before relying on it. Not medical advice.

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