510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050704Substantially Equivalent

Modification to: Revolution Xr/d Digital Radiographic Imaging System with Image Pasting and Autopositioning

General Electric Co., Milwaukee WI / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050704 is the FDA 510(k) clearance record for MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING, a class II device, cleared for General Electric Co. on under FDA product code KPR (System, X-Ray, Stationary). FDA records list 256 510(k) clearances for General Electric Co., from to . As of , FDA records show 2 recalls naming K050704.

Clearance record

Decision date
Received
(21 days to decision)
Product code
KPR System, X-Ray, Stationary
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
General Electric Co. P.O. Box 414, Milwaukee WI
510(k) summary
Summary PDF
Third party review
No

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