510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K061976Substantially Equivalent

Ckis-004A Injector Synchronization Option

Toshiba America Medical Systems, In.C, Tustin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061976 is the FDA 510(k) clearance record for CKIS-004A INJECTOR SYNCHRONIZATION OPTION, a class II device, cleared for Toshiba America Medical Systems, In.C on under FDA product code DXT (Injector And Syringe, Angiographic). FDA records list 146 510(k) clearances for Toshiba America Medical Systems, In.C, from to . As of , FDA records show no recalls naming K061976.

Clearance record

Decision date
Received
(76 days to decision)
Product code
DXT Injector And Syringe, Angiographic
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Toshiba America Medical Systems, In.C 2441 Michelle Dr., Tustin CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code DXT

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