WatchMate Software— 510(k) K260300
Substantially EquivalentAnumana, Inc.
FDA 510(k) clearance K260300 for WatchMate Software, Substantially Equivalent on 2026-06-15. Applicant: Anumana, Inc.. Device class: 2.
Summary
Anumana's WatchMate Software is filed under QIH, automated radiological image processing software. The record doesn't describe the software beyond its name and the code name.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Anumana filed from Cambridge, Massachusetts. The decision came 136 calendar days after receipt (January 30 to June 15, 2026).
Clearance details
- Applicant
- Anumana, Inc.
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
Recent devices under product code QIH
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