510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012941Substantially Equivalent

Drystar, Model 4500M

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

K012941 is the FDA 510(k) clearance record for DRYSTAR, MODEL 4500M, a class II device, cleared for Agfa Corp. on under FDA product code LMC (Camera, Multi Format, Radiological). FDA records list 4 510(k) clearances for Agfa Corp., from to . As of , FDA records show no recalls naming K012941.

Clearance record

Decision date
Received
(90 days to decision)
Product code
LMC Camera, Multi Format, Radiological
Regulation
21 CFR 892.2040
Device class
Class II
Review panel
Radiology
Applicant
Agfa Corp. 12300 Twinbrook Pkwy.,Ste 625, Rockville MD
510(k) summary
Summary
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