Cr Mammography System with Dx-M Digitizer

by Agfa Healthcare N.V. FDA registration: Belgium 510(k)

510(k) K111324 Product code MUE

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK111324	Date22 Dec 2011Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number: K111324
FDA Product Code: MUE

Device Class: Class II
Regulation: 21 CFR Part 892.1715
Advisory Committee: Radiology
FDA Decision: SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K111324 24 fields · synced 22 Oct 2026