DeepHealth, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “DeepHealth, Inc.” (first 2021, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 138 days. Since 2017 the median was 138 days, against 132 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 137 |
| 2022 | 2 | 130 |
| 2023 | 0 | — |
| 2024 | 3 | 20 |
| 2025 | 2 | 121 |
| 2026 | 2 | 173 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name DeepHealth, Inc. took a median 138 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | 5 | 5 |
| QIH | Automated Radiological Image Processing Software | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | 1 | 1 |
Review panels
- Radiology (10)
Most recent DeepHealth, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253825 | Saige-Dx | QDQ | 2026-06-15 | 196 |
| K254131 | BAC | QIH | 2026-05-21 | 150 |
| K251873 | Saige-Dx | QDQ | 2025-08-11 | 54 |
| K243703 | TechLive | LLZ | 2025-06-05 | 188 |
| K243705 | Saige-Density (2.5.0) | QIH | 2024-12-19 | 20 |
| K243688 | Saige-Dx (3.1.0) | QDQ | 2024-12-19 | 20 |
| K241747 | Saige-Dx | QDQ | 2024-11-18 | 153 |
| K222275 | Saige-Density | QIH | 2022-12-16 | 140 |
| K220105 | Saige-Dx | QDQ | 2022-05-12 | 120 |
| K203517 | Saige-Q | QFM | 2021-04-16 | 137 |
Recalls
openFDA lists no recalls under a recalling firm named DeepHealth, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under DeepHealth, Inc.?
FDA lists 10 510(k) clearances under the applicant name “DeepHealth, Inc.” (first 2021, latest 2026), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by DeepHealth, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name DeepHealth, Inc. is 138 days. Since 2017: 138 days, versus 132 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under DeepHealth, Inc.?
The most frequent FDA product codes under this applicant name are QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer, 5); QIH (Automated Radiological Image Processing Software, 3); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 10 DeepHealth, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QDQ, DeepHealth, Inc.'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.