Cleared Traditional

K111324 - CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER

K111324 is an FDA 510(k) clearance for CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER, manufactured by Agfa Healthcare N.V.. The device is a Class 2 Radiology device with product code MUE cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K111324 · Agfa Healthcare N.V. · Radiology device
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Dec 2011
Decision
225d
Days
Class 2
Risk

K111324 is an FDA 510(k) clearance for the CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER. Classified as Full Field Digital, System, X-ray, Mammographic (product code MUE), Class II - Special Controls.

Submitted by Agfa Healthcare N.V. (Greenville, US). The FDA issued a Cleared decision on December 22, 2011 after a review of 225 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1715 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Agfa Healthcare N.V. devices

FDA 510(k) Submission Details - K111324

510(k) Number K111324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2011
Decision Date December 22, 2011
Days to Decision 225 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 107d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUE Device Classification - Class 2, Special Controls

Product Code MUE Full Field Digital, System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1715
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MUE Full Field Digital, System, X-ray, Mammographic

All 40
Devices cleared under the same product code (MUE) and FDA review panel - the closest regulatory comparables to K111324.
ASPIRE HD PLUS, ASPIRE HD-S
K121674 · Fujifilm Medical System U.S.A., Inc. · Sep 2012
KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)
K120246 · Carestream Health, Inc. · Aug 2012
KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM
K110717 · Konica Minolta Medical & Graphic, Inc. · Dec 2011
ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM)
K111646 · Fujifilm Medical System U.S.A., Inc. · Dec 2011
MAMMODIAGNOST DR
K110572 · Philips Medical Systems · Sep 2011
ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
K110729 · Fujifilm Medical Systems U.S.A, Inc. · Sep 2011