Cleared Special

K123995 - MICRODOSE SI

K123995 is an FDA 510(k) clearance for MICRODOSE SI, manufactured by Philips Digital Mammography Sweden AB. The device is a Class 2 Radiology device with product code MUE cleared through the Special 510(k) pathway after a 37-day FDA review.

K123995 · Philips Digital Mammography Sweden AB · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
37d
Days
Class 2
Risk

K123995 is an FDA 510(k) clearance for the MICRODOSE SI. 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 February 1, 2013 after a review of 37 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K123995

510(k) Number K123995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2012
Decision Date February 01, 2013
Days to Decision 37 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 107d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

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 55
Devices cleared under the same product code (MUE) and FDA review panel - the closest regulatory comparables to K123995.
MAMMOMAT INSPIRATION PRIME
K123520 · Siemens Medical Solutions USA, Inc. · Jun 2013
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K122510 · Icrco, Inc. · Apr 2013
MAMMOMAL INSPIRATION
K122286 · Siemens Medical Solutions USA, Inc. · Feb 2013
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
K123873 · Hologic, Inc. · Jan 2013
PLANMED NUANCE DIGIGUIDE
K121963 · Planmed OY · Nov 2012
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K121674 · Fujifilm Medical System U.S.A., Inc. · Sep 2012