Saige-Dx (3.1.0)— 510(k) K243688
Substantially EquivalentDeepHealth, Inc.
FDA 510(k) clearance K243688 for Saige-Dx (3.1.0), Substantially Equivalent on 2024-12-19. Applicant: DeepHealth, Inc.. Device class: 2.
Clearance details
- Applicant
- DeepHealth, Inc.
- Product code
- Code QDQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2090
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Somerville, MA, US
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