Cleared Traditional

K133972 - ASPIRE CRISTALLE

K133972 is the FDA 510(k) clearance for ASPIRE CRISTALLE by Fujifilm Medical Systems U.S.A, Inc.. It is a Class 2 Radiology device (product code MUE) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K133972 · Fujifilm Medical Systems U.S.A, Inc. · Radiology device
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Mar 2014
Decision
89d
Days
Class 2
Risk

K133972 is an FDA 510(k) clearance for the ASPIRE CRISTALLE. Classified as Full Field Digital, System, X-ray, Mammographic (product code MUE), Class II - Special Controls.

Submitted by Fujifilm Medical Systems U.S.A, Inc. (Stamford, US). The FDA issued a Cleared decision on March 25, 2014 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fujifilm Medical Systems U.S.A, Inc. devices

Submission Details

510(k) Number K133972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2013
Decision Date March 25, 2014
Days to Decision 89 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
18d faster than avg
Panel avg: 107d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 38
Devices cleared under the same product code (MUE) and FDA review panel - the closest regulatory comparables to K133972.
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