510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231892Substantially Equivalent

Definium Pace Select

GE Hualun Medical Systems Co., Ltd., Beijing, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231892 is the FDA 510(k) clearance record for Definium Pace Select, a class II device, cleared for Ge Hualun Medical Systems Co. , Ltd. on under FDA product code KPR (System, X-Ray, Stationary). FDA records list 12 510(k) clearances for Ge Hualun Medical Systems Co. , Ltd., from to . As of , FDA records show one recall naming K231892.

Clearance record

Decision date
Received
(76 days to decision)
Product code
KPR System, X-Ray, Stationary
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
Ge Hualun Medical Systems Co. , Ltd. #1, Yong Chang N. Rd., Beijing Economic Technological, Beijing, CN
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