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

Calibration Software For Radiology Displays

21 CFR 892.1940 / Radiology
FDA source (opens on fda.gov)

SHN is the FDA product code for Calibration Software For Radiology Displays, a class I device type, regulated under 21 CFR 892.1940. FDA's definition for this code reads: "The software is intended to calibrate displays to meet quality criteria that enable their use in primary diagnostic radiology". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SHN
Device name
Calibration Software For Radiology Displays
FDA definition
The software is intended to calibrate displays to meet quality criteria that enable their use in primary diagnostic radiology.
Regulation
21 CFR 892.1940
Device class
Class I
Review panel
Radiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SHN

By decision year
1 clearance under product code SHN with a decision year between 2026 and 2026, 2026 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SHN by decision year
YearClearances
20261

Applicants with the most clearances

Product code SHN
Applicants holding the most 510(k) clearances under product code SHN
ApplicantClearances
Apple Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code