Saige-Dx
FDA 510(k) clearance K241747 · decided 2024-11-18
Clearance details
- K-number
- K241747
- Device name
- Saige-Dx
- Applicant
- DeepHealth, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-06-18
- Decision date
- 2024-11-18
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- QDQ
- Device class
- 2
- Regulation number
- 892.2090
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Somerville, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| See-Mode Augmented Reporting Tool, Breast (SMART-B) (K260303) | See-Mode Technologies Pty, Ltd. | 2026-07-28 |
| MammoScreen® (5) (K260714) | Therapixel | 2026-06-26 |
| Saige-Dx (K253825) | DeepHealth, Inc. | 2026-06-15 |
| DeepHealth ProstateAI (K253682) | Quantib B.V. | 2026-04-29 |
| Lunit INSIGHT MMG (v1.1.10) (K260320) | Lunit, Inc. | 2026-04-23 |
| Lunit INSIGHT DBT (V1.2) (K253796) | Lunit, Inc. | 2026-03-26 |
| Median LCS (internal name) / eyonis LCS (trade name) (1.0) (K251474) | Median Technologies | 2026-02-06 |
| Saige-Dx (K251873) | DeepHealth, Inc. | 2025-08-11 |
| Genius AI Detection 2.0 (K243341) | Hologic, Inc. | 2025-07-31 |
| MammoScreen® (4) (K243679) | Therapixel | 2025-07-03 |
| QP-Prostate® CAD (K242683) | Quibim S.L. | 2025-03-18 |
| Prostate MR AI (VA10A) (K241770) | Siemens Healthcare GmbH | 2025-03-05 |
Recalls involving this device
No recalls on record reference this clearance.