510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111324Substantially Equivalent

Cr Mammography System with Dx-M Digitizer

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

K111324 is the FDA 510(k) clearance record for CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER, a class II device, cleared for Agfa Healthcare N.V. on under FDA product code MUE (Full Field Digital, System, X-Ray, Mammographic). FDA records list 39 510(k) clearances for Agfa Healthcare N.V., from to . As of , FDA records show no recalls naming K111324.

Clearance record

Decision date
Received
(225 days to decision)
Product code
MUE Full Field Digital, System, X-Ray, Mammographic
Regulation
21 CFR 892.1715
Device class
Class II
Review panel
Radiology
Applicant
Agfa Healthcare N.V. 10 S. Academy St., Greenville SC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MUE

Trailing 12 months
4 clearances under product code MUE in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MUE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260