SHN — Calibration Software For Radiology Displays Class I

FDA Device Classification

Classification Details

Product Code
SHN
Device Class
Class I
Regulation Number
892.1940
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Definition

The software is intended to calibrate displays to meet quality criteria that enable their use in primary diagnostic radiology.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253582appleMedical Imaging Calibration Feature (MICF)April 1, 2026