510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K081976Substantially Equivalent

Impax Ma3000 Diagnostic Pacs Workstation

AGFA Healthcare Corp., Greenville SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081976 is the FDA 510(k) clearance record for IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION, a class II device, cleared for Agfa Healthcare Corporation on under FDA product code LLZ (System, Image Processing, Radiological). FDA records list 39 510(k) clearances for Agfa Healthcare Corporation, from to . As of , FDA records show one recall naming K081976.

Clearance record

Decision date
Received
(17 days to decision)
Product code
LLZ System, Image Processing, Radiological
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
Agfa Healthcare Corporation 10 S. Academy St., Greenville SC
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code LLZ

Trailing 12 months
47 clearances under product code LLZ in the twelve months to October 2026, July 2026 the highest month at 8.
Show the numbers
Monthly 510(k) clearances under FDA product code LLZ, trailing twelve months
MonthClearances
November 20254
December 20251
January 20263
February 20264
March 20266
April 20262
May 20265
June 20265
July 20268
August 20263
September 20266
October 20260