Cleared Traditional

K120255 - PHILIPS MICRODOSE

K120255 is an FDA 510(k) clearance for PHILIPS MICRODOSE, manufactured by Philips Digital Mammography Sweden AB. The device is a Class 2 Radiology device with product code MUE cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K120255 · Philips Digital Mammography Sweden AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
83d
Days
Class 2
Risk

K120255 is an FDA 510(k) clearance for the PHILIPS MICRODOSE. Classified as Full Field Digital, System, X-ray, Mammographic (product code MUE), Class II - Special Controls.

Submitted by Philips Digital Mammography Sweden AB (Solna, SE). The FDA issued a Cleared decision on April 19, 2012 after a review of 83 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 Philips Digital Mammography Sweden AB devices

FDA 510(k) Submission Details - K120255

510(k) Number K120255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2012
Decision Date April 19, 2012
Days to Decision 83 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 107d · This submission: 83d
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 45
Devices cleared under the same product code (MUE) and FDA review panel - the closest regulatory comparables to K120255.
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