510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853737Substantially Equivalent

Vest(ambulatory Ventricular Evaluating System)

Mirion Technologies (Capintec), Inc., Pittsburgh PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853737 is the FDA 510(k) clearance record for VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM), a class I device, cleared for Capintec, Inc. on under FDA product code IYY (Synchronizer, Electrocardiograph, Nuclear). FDA records list 15 510(k) clearances for MIRION TECHNOLOGIES (CAPINTEC), INC, from to . As of , FDA records show no recalls naming K853737.

Clearance record

Decision date
Received
(160 days to decision)
Product code
IYY Synchronizer, Electrocardiograph, Nuclear
Regulation
21 CFR 892.1410
Device class
Class I
Review panel
Radiology
Applicant
Capintec, Inc. 540 Alpha Dr., Pittsburgh PA
Third party review
No

Clearances, product code IYY

Trailing 12 months

FDA records hold no clearances under product code IYY in the trailing twelve months.

FDA records show no clearances under product code IYY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IYY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260