510(k) K253582
- Device
- Medical Imaging Calibration Feature (MICF)
- Applicant
- Apple, Inc.
- 510(k) number
- K253582
- Product code
- SHN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-01
- Date received
- 2025-11-17
- Regulation
- 892.1940
- Classification name
- Calibration Software For Radiology Displays
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Lynda Ikejimba
- Address
- 1 Apple Park Way Cupertino CA US 95014 95014
FDA Registration Numbers
- 3014343954