Medical Imaging Calibration Feature (MICF)— 510(k) K253582

Substantially Equivalent

Apple, 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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