Artificial intelligence medical devices are named, cleared products that run a model on a signal or a scan and return a flag, a measurement, or a guided acquisition. This page is a list of those products. It is not how to develop a device, not a QMS, and not a PYCAD catalog.
If you meant how a device is built → medical device development process. If you meant FDA class → 510(k) / PMA / De Novo → FDA medical device approval process. If you meant QMS / risk / GTM → those 699 keepers. If you meant generic AI regulation (EU AI Act) → AI regulatory compliance. If you meant diagnosis as a workflow → AI for medical diagnosis.
PYCAD builds custom web DICOM viewers and imaging models. It does not sell a cleared AI device, and it is not item one on this list. The old ranking that put PYCAD in a “top 10 devices” table was an ad. Dropped.
Nine products, one pattern
Most of these are assistive: a radiologist or a cardiologist still signs. A few are autonomous for one narrow label. Names change (acquisitions). The job usually does not.
| Product | Job | Input | Who acts |
|---|---|---|---|
| LumineticsCore (Digital Diagnostics; was IDx-DR) | Autonomous “more than mild diabetic retinopathy” at the point of care | Fundus photo (labeled for Topcon NW400) | The system returns the result. No eye-care specialist has to read the image for that one claim. |
| Viz.ai | Stroke / LVO triage and team notify | Head / CTA CT | Specialist still treats. The product is the clock and the page. |
| Aidoc | Always-on worklist flags (ICH, PE, C-spine, and a long list of other clearances) | CT / X-ray / some MRI | Radiologist. Parallel to the read, not instead of it. |
| Nanox.AI (was Zebra Medical Vision) | Opportunistic findings on studies already being read (fracture, coronary calcium, and siblings) | CT / X-ray / mammo depending on the algorithm | Radiologist. Population-health add-on, not a new exam. |
| Tempus Pixel (was Arterys) | Cloud quantification — cardiac MRI volumes, lung / liver tools | MRI / CT in a browser | Radiologist / cardiologist. Measurement, not a diagnosis. |
| SubtlePET / SubtleMR (Subtle Medical) | Denoise so you can run a faster or lower-dose acquisition | PET or MRI already on the scanner | The image still gets read. The product is the reconstruction, not a finding. |
| Caption Guidance (GE HealthCare; was Caption Health) | Real-time probe guidance so a non-sonographer can capture a diagnostic echo | Ultrasound cine | The operator still acquires; a clinician still interprets. |
| Butterfly iQ+ | Single-probe handheld ultrasound with AI helpers (bladder volume, EF-style tools) | Ultrasound on a phone / tablet | The clinician holding the probe. Hardware plus software, not a PACS AI. |
| KardiaMobile 6L (AliveCor) | Six-lead personal ECG, AI rhythm labels (AF and siblings) | 30-second ECG from the electrodes | The user and their clinician. Not an emergency service. |
The one that is actually autonomous
LumineticsCore (FDA De Novo as IDx-DR) is the usual example of a system that returns a clinical result without a specialist reading the photo. Abràmoff et al., npj Digital Medicine 2018 (NCT02963441): sensitivity 87.2% (95% CI 81.8–91.2) and specificity 90.7% (88.3–92.7) for more than mild DR against a reading-center grade. Paper: doi:10.1038/s41746-018-0040-6. Indicated with the Topcon NW400, adults already diagnosed with diabetes, that one claim. It does not screen for other eye disease. Current product page: Digital Diagnostics.
Worklist and reconstruction (not a new modality)
Viz.ai and Aidoc sit on the CT that was already ordered. The value is a page and a bumped worklist, not a new scanner. Vendor time-to-treatment numbers move; treat them as marketing until you read the specific trial. Nanox.AI is the same idea aimed at incidental / opportunistic labels on a study you were reading for something else.
Subtle Medical is a different job: make the acquisition cheaper (time or dose) and still readable. It does not flag a bleed. Tempus Pixel (Arterys, acquired 2022) is quantification in a browser — volumes and segmentations, not a stroke pager.
Guided acquisition and pocket hardware
Caption Guidance (GE HealthCare bought Caption Health in 2023) talks the probe into a diagnostic echo window. Butterfly iQ+ is a semiconductor probe plus an app; the AI is helpers on a handheld, not a hospital worklist. KardiaMobile 6L is a consumer-clinic ECG. None of these is “PYCAD, but portable.”
How to read a list like this
- Clearance is per claim and per input. “FDA-cleared AI” is not a blanket.
- Assistive vs autonomous is the whole product. Do not import LumineticsCore’s autonomy onto an Aidoc flag.
- Names rot. Zebra → Nanox.AI. Arterys → Tempus Pixel. Caption Health → GE. Check the current IFU before you buy the old brand.
- This is not a ranked “best of.” No scores, no trophies, no PYCAD row.
What this page is not
- Not device development, QMS, PMS, GTM, or ISO 14971. 699 left this leftover on purpose.
- Not the FDA process article. Pointer only.
- Not a PYCAD device catalog or a “10 successful projects” ad.
- Not unsourced “66 minutes” / “75% dose” / “60% faster MRI” theater. Dropped.
If the work is a viewer or a model that has to live next to one of these, that is the imaging piece. Case studies.