DeviceClearance

Product code PGY— Radiology

21HQ513D

Classification name
Display, Diagnostic Radiology
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Total cleared
136
First cleared
Most recent

FDA classification definition

“The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.”

— U.S. Food and Drug Administration, device classification record for product code PGY under 21 CFR 892.2050, via openFDA

Market context for product code PGY

FDA has cleared 136 devices under product code PGY between 2014 and 2026, filed by 19 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PGY

Recent clearances under product code PGY

1–100 of 136

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