510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K010275Substantially Equivalent

Drystar 4500 Printer, Model 4500

Agfa Medical Imaging, Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010275 is the FDA 510(k) clearance record for DRYSTAR 4500 PRINTER, MODEL 4500, a class II device, cleared for Agfa Medical Imaging on under FDA product code LMC (Camera, Multi Format, Radiological). FDA records list one 510(k) clearance for Agfa Medical Imaging. As of , FDA records show no recalls naming K010275.

Clearance record

Decision date
Received
(87 days to decision)
Product code
LMC Camera, Multi Format, Radiological
Regulation
21 CFR 892.2040
Device class
Class II
Review panel
Radiology
Applicant
Agfa Medical Imaging 12300 Twinbrook Pkwy., Suite 625, Rockville MD
510(k) summary
Statement
Third party review
No

Clearances, product code LMC

Trailing 12 months

FDA records hold no clearances under product code LMC in the trailing twelve months.

FDA records show no clearances under product code LMC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LMC, 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 20260
October 20260