Cleared Traditional

K082450 - IDR

K082450 is an FDA 510(k) clearance for IDR, manufactured by Icrco, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K082450 · Icrco, Inc. · Radiology device
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Jun 2009
Decision
309d
Days
Class 2
Risk

K082450 is an FDA 510(k) clearance for the IDR. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Icrco, Inc. (Torrance, US). The FDA issued a Cleared decision on June 30, 2009 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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. Elevated predicate reliance profile. 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 - K082450

510(k) Number K082450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2008
Decision Date June 30, 2009
Days to Decision 309 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
202d slower than avg
Panel avg: 107d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 289
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K082450.
DX-D IMAGING PACKAGE
K092669 · Agfa Healthcare N.V. · Nov 2009
DIRECT DIGITIZER, REGIUS MODEL 210
K092717 · Konica Minolta Medical & Graphic, Inc. · Oct 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS
K092238 · Agfa Healthcare N.V. · Aug 2009
DIGITAL RADIOGRAPHY CXDI-60C
K091545 · Canon, Inc. · Jun 2009
DIGITAL RADIOGRAPHY MODEL CXDI-55G
K091435 · Canon, Inc. · May 2009
DIGITAL RADIOGRAPHY, MODEL CXDI-55C
K091436 · Canon, Inc. · May 2009