510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001112Substantially Equivalent

Ge Marquette Clinical Information Center, Ge Marquette Cic

General Electric Medical Systems Information Techn, Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001112 is the FDA 510(k) clearance record for GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC, a class II device, cleared for General Electric Medical Systems Information Techn on under FDA product code DXJ (Display, Cathode-Ray Tube, Medical). FDA records list 33 510(k) clearances for General Electric Medical Systems Information Techn, from to . As of , FDA records show no recalls naming K001112.

Clearance record

Decision date
Received
(69 days to decision)
Product code
DXJ Display, Cathode-Ray Tube, Medical
Regulation
21 CFR 870.2450
Device class
Class II
Review panel
Cardiovascular
Applicant
General Electric Medical Systems Information Techn 8200 W. Tower Ave., Milwaukee WI
510(k) summary
Summary
Third party review
No

Clearances, product code DXJ

Trailing 12 months

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

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