Cleared Traditional

K122286 - MAMMOMAL INSPIRATION

K122286 is an FDA 510(k) clearance for MAMMOMAL INSPIRATION, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code MUE cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K122286 · Siemens Medical Solutions USA, Inc. · Radiology device
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Feb 2013
Decision
207d
Days
Class 2
Risk

K122286 is an FDA 510(k) clearance for the MAMMOMAL INSPIRATION. Classified as Full Field Digital, System, X-ray, Mammographic (product code MUE), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Mavern, US). The FDA issued a Cleared decision on February 22, 2013 after a review of 207 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 Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K122286

510(k) Number K122286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2012
Decision Date February 22, 2013
Days to Decision 207 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
100d slower than avg
Panel avg: 107d · This submission: 207d
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 54
Devices cleared under the same product code (MUE) and FDA review panel - the closest regulatory comparables to K122286.
SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)
K131885 · GE Medical Systems SCS · Sep 2013
MAMMOMAT INSPIRATION PRIME
K123520 · Siemens Medical Solutions USA, Inc. · Jun 2013
ICRCO 3600M
K122510 · Icrco, Inc. · Apr 2013
MICRODOSE SI
K123995 · Philips Digital Mammography Sweden AB · Feb 2013
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
K123873 · Hologic, Inc. · Jan 2013
PLANMED NUANCE DIGIGUIDE
K121963 · Planmed OY · Nov 2012