Saige-Density
510(k) K222275
Saige-Density is a medical device (FDA Class II; FDA product code QIH, Automated Radiological Image Processing Software) made by DeepHealth, Inc., cleared under FDA 510(k) K222275 on 16 Dec 2022, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK222275 | Date16 Dec 2022 | StatusActive |
Official records
- FDA 510(k) database K222275
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QIH
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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