510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K093816Substantially Equivalent

Digital Radiography System, Models Galaxy 900 and 1600

Medien International Co, Ltd., Echo OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093816 is the FDA 510(k) clearance record for DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600, a class II device, cleared for Medien International Co, Ltd. on under FDA product code KPR (System, X-Ray, Stationary). FDA records list 3 510(k) clearances for Medien International Co, Ltd., from to . As of , FDA records show no recalls naming K093816.

Clearance record

Decision date
Received
(298 days to decision)
Product code
KPR System, X-Ray, Stationary
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
Medien International Co, Ltd. 77325 Joyce Way, Echo OR
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