510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K062265Substantially Equivalent

CT Expres III Contrast Media Delivery System

Swiss Medical Care S.A., Flemington NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062265 is the FDA 510(k) clearance record for CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM, a class II device, cleared for Swiss Medical Care S.A. on under FDA product code IZQ (Injector, Contrast Medium, Automatic). FDA records list one 510(k) clearance for Swiss Medical Care S.A. As of , FDA records show no recalls naming K062265.

Clearance record

Decision date
Received
(144 days to decision)
Product code
IZQ Injector, Contrast Medium, Automatic
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Swiss Medical Care S.A. 32 Stratton Ct., Flemington NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IZQ

Trailing 12 months
3 clearances under product code IZQ in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IZQ, trailing twelve months
MonthClearances
November 20252
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260