Ultrasound AI: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Ultrasound AI”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SHE | Radiological Software System For Delivery Date Prediction | 1 | 0 |
Review panels
- Radiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN250007 | De Novo | Radiological Software System For Delivery Date Prediction | 2026-02-11 |
Recalls
openFDA lists no recalls under a recalling firm named Ultrasound AI.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ultrasound Medical Devices, Inc. (2 510(k)s)
- Ultrasound Biotechnology (Shanghai) Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ultrasound AI?
FDA lists 0 510(k) clearances under the applicant name “Ultrasound AI”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Ultrasound AI?
The most frequent FDA product codes under this applicant name are SHE (Radiological Software System For Delivery Date Prediction, 1).
Next steps
- See all 0 Ultrasound AI clearances with predicates and recalls
- Run predicate analysis for product code SHE, Ultrasound AI's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.