510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K983826Substantially Equivalent

3S Injector-CT Contrast Delivery System

Unimachs Corp., Bethesda MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983826 is the FDA 510(k) clearance record for 3S INJECTOR-CT CONTRAST DELIVERY SYSTEM, a class II device, cleared for Unimachs Corp. on under FDA product code DXT (Injector And Syringe, Angiographic). FDA records list one 510(k) clearance for Unimachs Corp. As of , FDA records show no recalls naming K983826.

Clearance record

Decision date
Received
(511 days to decision)
Product code
DXT Injector And Syringe, Angiographic
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Unimachs Corp. 7475 Wisconsin Ave.,, Bethesda MD
510(k) summary
Summary
Third party review
No

Clearances, product code DXT

Trailing 12 months
6 clearances under product code DXT in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DXT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20261
May 20263
June 20260
July 20260
August 20260
September 20260
October 20260