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

Display, Diagnostic Radiology

21 CFR 892.2050 / Radiology
FDA source (opens on fda.gov)

PGY is the FDA product code for Display, Diagnostic Radiology, a class II device type, regulated under 21 CFR 892.2050. FDA's definition for this code reads: "The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners". As of , FDA records hold 135 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
PGY
Device name
Display, Diagnostic Radiology
FDA definition
The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
136
Ingested recalls
6

Clearances, product code PGY

By decision year
136 clearances under product code PGY with a decision year between 2014 and 2026, 2016 the highest year at 18.
Show the numbers
510(k) clearances under FDA product code PGY by decision year
YearClearances
201414
201516
201618
201711
20185
201911
202012
20217
202210
202317
202410
20253
20262

Applicants with the most clearances

Product code PGY
Applicants holding the most 510(k) clearances under product code PGY
ApplicantClearances
Nanjing Jusha Display Technology Co., Ltd22
Eizo Corporation21
JVCKENWOOD Corporation16
Barco N.V.13
Shenzhen Beacon Display Technology Co., Ltd.13
LG Electronics.Inc12
Wide Corporation8
Qingdao Hisense Medical Equipment Co.,Ltd.5
Wide Corporation5
Eizo Corporation4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order