Cleared Traditional

K130704 - MICRODOSE SI

K130704 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 Traditional 510(k) pathway after a 273-day FDA review.

K130704 · Philips Digital Mammography Sweden AB · Radiology device
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Dec 2013
Decision
273d
Days
Class 2
Risk

K130704 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 December 13, 2013 after a review of 273 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 Philips Digital Mammography Sweden AB devices

FDA 510(k) Submission Details - K130704

510(k) Number K130704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2013
Decision Date December 13, 2013
Days to Decision 273 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
166d slower than avg
Panel avg: 107d · This submission: 273d
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 K130704.
Senographe Pristina
K162268 · Ge Healthcare · Nov 2016
MAMMOMAT Fusion
K151645 · Siemens Medical Solutions USA, Inc. · Sep 2015
ASPIRE CRISTALLE
K133972 · Fujifilm Medical Systems U.S.A, Inc. · Mar 2014
SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)
K131885 · GE Medical Systems SCS · Sep 2013
MAMMOMAT INSPIRATION PRIME
K123520 · Siemens Medical Solutions USA, Inc. · Jun 2013
MAMMOMAL INSPIRATION
K122286 · Siemens Medical Solutions USA, Inc. · Feb 2013