DeviceClearance

Product code SHN— Radiology

Medical Imaging Calibration Feature (MICF)

Classification name
Calibration Software For Radiology Displays
Device class
Class 1
Regulation
21 CFR 892.1940
Advisory panel
Radiology
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code SHN under 21 CFR 892.1940, via openFDA

Market context for product code SHN

FDA has cleared 1 device under product code SHN, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code SHN

Recent clearances under product code SHN

Data sourced from openFDA. This site is unofficial and independent of the FDA.