510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182183Substantially Equivalent

Gc70, Gu60a, Gu60a-65, Gf50, Gr50a ; Gr40cw ; Gm85 ; Gc85a

Samsung Electronics Co., Ltd., Suwon-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182183 is the FDA 510(k) clearance record for GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A, a class II device, cleared for Samsung Electronics Co., Ltd. on under FDA product code KPR (System, X-Ray, Stationary). FDA records list 42 510(k) clearances for Samsung Electronics Co., Ltd., from to . As of , FDA records show no recalls naming K182183.

Clearance record

Decision date
Received
(116 days to decision)
Product code
KPR System, X-Ray, Stationary
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
Samsung Electronics Co., Ltd. 129 Samsung-Ro, Yeongtong-Gu, Suwon-Si, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KPR

Trailing 12 months
7 clearances under product code KPR in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KPR, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20262
September 20261
October 20260