Saige-Dx— 510(k) K253825
Substantially EquivalentDeepHealth, Inc.
FDA 510(k) clearance K253825 for Saige-Dx, Substantially Equivalent on 2026-06-15. Applicant: DeepHealth, Inc.. Device class: 2.
Summary
Saige-Dx from DeepHealth is filed under QDQ, radiological computer-assisted detection and diagnosis software for lesions suspicious for cancer. The record doesn't describe the software beyond its name and the code name.
Class II, 21 CFR 892.2090. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
DeepHealth filed from Somerville, Massachusetts. Review took 196 calendar days (December 1, 2025 to June 15, 2026).
Clearance details
- Applicant
- DeepHealth, Inc.
- Product code
- Product code QDQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2090
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerville, MA, US
Recent devices under product code QDQ
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