Medical Imaging Calibration Feature (MICF)
FDA 510(k) clearance K253582 · decided 2026-04-01
Clearance details
- K-number
- K253582
- Device name
- Medical Imaging Calibration Feature (MICF)
- Applicant
- Apple, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-11-17
- Decision date
- 2026-04-01
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- SHN
- Device class
- 1
- Regulation number
- 892.1940
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Cupertino, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.