510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012389Substantially Equivalent

Revolution Xr/d Digital Radiographic Imaging System

GE Healthcare, Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012389 is the FDA 510(k) clearance record for REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM, a class II device, cleared for Ge Medical Systems, Inc. on under FDA product code KPR (System, X-Ray, Stationary). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show 4 recalls naming K012389.

Clearance record

Decision date
Received
(14 days to decision)
Product code
KPR System, X-Ray, Stationary
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
Ge Medical Systems, Inc. P.O. Box 414, Milwaukee WI
510(k) summary
Summary
Third party review
Yes

Clearances, product code KPR

Trailing 12 months
7 clearances under product code KPR in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KPR, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20262
September 20261
October 20260