Saige-Q
FDA 510(k) clearance K203517 · decided 2021-04-16
Clearance details
- K-number
- K203517
- Device name
- Saige-Q
- Applicant
- DeepHealth, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-11-30
- Decision date
- 2021-04-16
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- QFM
- Device class
- 2
- Regulation number
- 892.2080
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch DeepHealth
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CXRDetectAI (K253751) | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-07-08 |
| MammoSightAI (K252954) | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-05-04 |
| CogNet AI-MT+ (K252482) | Medcognetics, Inc. | 2025-12-11 |
| Annalise Enterprise (K250831) | Annalise-Ai | 2025-04-23 |
| Rayvolve PTX-PE (K243808) | AZmed | 2025-03-21 |
| BriefCase-Triage (K243548) | Aidoc Medical , Ltd. | 2024-12-11 |
| VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage (K241439) | Vuno, Inc. | 2024-11-15 |
| CINA-VCF (K240612) | Avicenna.Ai | 2024-05-31 |
| VinDr-Mammo (K233108) | Vinbigdata Joint Stock Company | 2024-05-23 |
| SmartChest (K232410) | Milvue | 2024-05-10 |
| Radify Triage (K231871) | Envisionit Deepai, Ltd. | 2024-01-17 |
| BraveCX (K223754) | Bering, Ltd. | 2023-11-09 |
Recalls involving this device
No recalls on record reference this clearance.