510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K983314Substantially Equivalent

Premica CT Contrast Media Delivery System

Nycomed Amersham Imaging, North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983314 is the FDA 510(k) clearance record for PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM, a class II device, cleared for Nycomed Amersham Imaging on under FDA product code IZQ (Injector, Contrast Medium, Automatic). FDA records list one 510(k) clearance for Nycomed Amersham Imaging. As of , FDA records show no recalls naming K983314.

Clearance record

Decision date
Received
(151 days to decision)
Product code
IZQ Injector, Contrast Medium, Automatic
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Nycomed Amersham Imaging 49 Plain St., North Attleboro MA
510(k) summary
Summary
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