Affinity— 510(k) K253835
Substantially EquivalentHermes Medical Solutions AB
FDA 510(k) clearance K253835 for Affinity, Substantially Equivalent on 2026-07-31. Applicant: Hermes Medical Solutions AB. Device class: 2.
Summary
Affinity from Hermes Medical Solutions is filed under QIH, automated radiological image processing software. The name is generic, and the record doesn't describe what the software processes or outputs.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).
Hermes Medical Solutions filed from Stockholm, Sweden. The decision came 242 calendar days after receipt (December 1, 2025 to July 31, 2026).
Clearance details
- Applicant
- Hermes Medical Solutions AB
- 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
- Stockholm, SE
Recent devices under product code QIH
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