510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K890636Substantially Equivalent

Cardiac Computation Software Package

Elscint, Inc., Hackensack NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890636 is the FDA 510(k) clearance record for CARDIAC COMPUTATION SOFTWARE PACKAGE, a class II device, cleared for Elscint, Inc. on under FDA product code JOP (Transducer, Ultrasonic). FDA records list 94 510(k) clearances for Elscint, Inc., from to . As of , FDA records show no recalls naming K890636.

Clearance record

Decision date
Received
(180 days to decision)
Product code
JOP Transducer, Ultrasonic
Regulation
21 CFR 870.2880
Device class
Class II
Review panel
Cardiovascular
Applicant
Elscint, Inc. 505 Main St., Hackensack NJ
Third party review
No

Clearances, product code JOP

Trailing 12 months

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

FDA records show no clearances under product code JOP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JOP, 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