510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K172435Substantially Equivalent

Galaxy R Digital Radiography Upgrade

Medien International Co, Ltd., Anyang-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172435 is the FDA 510(k) clearance record for Galaxy R Digital Radiography Upgrade, a class II device, cleared for Medien International Co, Ltd. on under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)). FDA records list 3 510(k) clearances for Medien International Co, Ltd., from to . As of , FDA records show no recalls naming K172435.

Clearance record

Decision date
Received
(63 days to decision)
Product code
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
Medien International Co, Ltd. Medien Office Tower, 50, Heungan-Daero 427 Beon-Gil Dongan-G, Anyang-Si, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQB

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