510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K053356Substantially Equivalent

Modification to: Cic Pro Clinical Information Center Central Station

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

K053356 is the FDA 510(k) clearance record for MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION, a class II device, cleared for Ge Medical Systems Information Technologies on under FDA product code DXJ (Display, Cathode-Ray Tube, Medical). FDA records list 171 510(k) clearances for Ge Medical Systems Information Technologies, from to . As of , FDA records show 2 recalls naming K053356.

Clearance record

Decision date
Received
(138 days to decision)
Product code
DXJ Display, Cathode-Ray Tube, Medical
Regulation
21 CFR 870.2450
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 DXJ

Trailing 12 months
1 clearance under product code DXJ in the twelve months to October 2026, September 2026 the highest month at 1.
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 20261
October 20260