510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K032635Substantially Equivalent

Drystar 5300 Medical Image Printer, Model 5300

Agfa Corp., Greenville SC / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032635 is the FDA 510(k) clearance record for DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300, a class II device, cleared for Agfa Corp. on under FDA product code LMC (Camera, Multi Format, Radiological). FDA records list 15 510(k) clearances for Agfa Corp., from to . As of , FDA records show no recalls naming K032635.

Clearance record

Decision date
Received
(29 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. 10 S. Academy St., Greenville SC
510(k) summary
Summary PDF
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