Cleared Traditional

K122510 - ICRCO 3600M

K122510 is an FDA 510(k) clearance for ICRCO 3600M, manufactured by Icrco, Inc.. The device is a Class 2 Radiology device with product code MUE cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K122510 · Icrco, Inc. · Radiology device
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Apr 2013
Decision
252d
Days
Class 2
Risk

K122510 is an FDA 510(k) clearance for the ICRCO 3600M. Classified as Full Field Digital, System, X-ray, Mammographic (product code MUE), Class II - Special Controls.

Submitted by Icrco, Inc. (Torrance, US). The FDA issued a Cleared decision on April 26, 2013 after a review of 252 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 Icrco, Inc. devices

FDA 510(k) Submission Details - K122510

510(k) Number K122510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2012
Decision Date April 26, 2013
Days to Decision 252 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 107d · This submission: 252d
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 K122510.
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
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
K123873 · Hologic, Inc. · Jan 2013
PLANMED NUANCE DIGIGUIDE
K121963 · Planmed OY · Nov 2012