Cleared Traditional

ICRCO 3600M (K122510) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 K122510.
Mammomat Fusion with Stereotactic Biopsy
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