AI4CMR v2.0— 510(k) K252084
Substantially EquivalentAi4medimaging Medical Solutions S.A.
FDA 510(k) clearance K252084 for AI4CMR v2.0, Substantially Equivalent on 2026-02-11. Applicant: Ai4medimaging Medical Solutions S.A.. Device class: 2.
Summary
Ai4medimaging Medical Solutions' AI4CMR v2.0 is filed under product code QIH, automated radiological image processing software. The record doesn't describe the software beyond its name and that code name.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Special 510(k).
Ai4medimaging Medical Solutions filed from Braga, Portugal. The substantially equivalent decision came 224 calendar days after receipt (July 2, 2025 to February 11, 2026).
Clearance details
- Applicant
- Ai4medimaging Medical Solutions S.A.
- 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
- Special
- Location
- Braga, PT
Recent devices under product code QIH
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