Medical Imaging Calibration Feature (MICF)— 510(k) K253582
Substantially EquivalentApple, Inc.
FDA 510(k) clearance K253582 for Medical Imaging Calibration Feature (MICF), Substantially Equivalent on 2026-04-01. Applicant: Apple, Inc.. Device class: 1.
Clearance details
- Applicant
- Apple, Inc.
- Product code
- Code SHN
- Device class
- Class 1
- Regulation
- 21 CFR 892.1940
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cupertino, CA, US
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