Cleared Traditional

MICRODOSE SI (K130704) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 28
Devices cleared under the same product code (MUE) and FDA review panel - the closest regulatory comparables to K130704.
Senographe Pristina
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K163252 · Siemens Medical Solutions USA, Inc. · Jan 2017
MAMMOMAT Fusion
K151645 · Siemens Medical Solutions USA, Inc. · Sep 2015
MAMMOMAT INSPIRATION PRIME
K123520 · Siemens Medical Solutions USA, Inc. · Jun 2013
MAMMOMAL INSPIRATION
K122286 · Siemens Medical Solutions USA, Inc. · Feb 2013