Cleared Traditional

K111646 - ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM)

Also marketed or referenced as:
FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR

K111646 is an FDA 510(k) clearance for ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM), manufactured by Fujifilm Medical System U.S.A., Inc.. The device is a Class 2 Radiology device with product code MUE cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K111646 · Fujifilm Medical System U.S.A., Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
178d
Days
Class 2
Risk

K111646 is an FDA 510(k) clearance for the ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM). Classified as Full Field Digital, System, X-ray, Mammographic (product code MUE), Class II - Special Controls.

Submitted by Fujifilm Medical System U.S.A., Inc. (Stamford, US). The FDA issued a Cleared decision on December 8, 2011 after a review of 178 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 Fujifilm Medical System U.S.A., Inc. devices

FDA 510(k) Submission Details - K111646

510(k) Number K111646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2011
Decision Date December 08, 2011
Days to Decision 178 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
71d slower than avg
Panel avg: 107d · This submission: 178d
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 54
Devices cleared under the same product code (MUE) and FDA review panel - the closest regulatory comparables to K111646.
KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM
K110717 · Konica Minolta Medical & Graphic, Inc. · Dec 2011
SENOGRAPHE DS, SENOGRAPHE ESSENTIAL
K110798 · General Electric Company · Dec 2011
CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER
K111324 · Agfa Healthcare N.V. · Dec 2011
GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L
K111434 · Giotto USA, LLC · Oct 2011
SENOGRAPH DS, SENOGRAPH ESSENSTIAL
K103485 · General Electric Company · Oct 2011
MAMMODIAGNOST DR
K110572 · Philips Medical Systems · Sep 2011