510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253582Substantially Equivalent

Medical Imaging Calibration Feature (MICF)

Apple Inc., Cupertino CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253582 is the FDA 510(k) clearance record for Medical Imaging Calibration Feature (MICF), a class I device, cleared for Apple, Inc. on under FDA product code SHN (Calibration Software For Radiology Displays). FDA's definition for product code SHN reads: "The software is intended to calibrate displays to meet quality criteria that enable their use in primary diagnostic radiology". FDA records list 10 510(k) clearances for Apple, Inc., from to . As of , FDA records show no recalls naming K253582.

Clearance record

Decision date
Received
(135 days to decision)
Product code
SHN Calibration Software For Radiology Displays
Regulation
21 CFR 892.1940
Device class
Class I
Review panel
Radiology
Applicant
Apple, Inc. 1 Apple Park Way, Cupertino CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SHN

Trailing 12 months
1 clearance under product code SHN in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SHN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260