510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K050614Substantially Equivalent

Muse Cardiology Information System

GE Medical Systems Information Technologies, Inc., Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050614 is the FDA 510(k) clearance record for MUSE CARDIOLOGY INFORMATION SYSTEM, a class II device, cleared for Ge Medical Systems Information Technologies on under FDA product code DQK (Computer, Diagnostic, Programmable). FDA records list 171 510(k) clearances for Ge Medical Systems Information Technologies, from to . As of , FDA records show one recall naming K050614.

Clearance record

Decision date
Received
(26 days to decision)
Product code
DQK Computer, Diagnostic, Programmable
Regulation
21 CFR 870.1425
Device class
Class II
Review panel
Cardiovascular
Applicant
Ge Medical Systems Information Technologies 8200 W. Tower Ave., Milwaukee WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQK

Trailing 12 months
26 clearances under product code DQK in the twelve months to October 2026, February 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DQK, trailing twelve months
MonthClearances
November 20250
December 20254
January 20262
February 20265
March 20260
April 20263
May 20261
June 20263
July 20264
August 20262
September 20261
October 20261