Cleared Traditional

K010772 - ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM (FDA 510(k) Clearance)

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

K010772 · Imaging Services, Inc. · Radiology device
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Aug 2001
Decision
162d
Days
Class 2
Risk

K010772 is an FDA 510(k) clearance for the ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Imaging Services, Inc. (North Holloywood, US). The FDA issued a Cleared decision on August 23, 2001 after a review of 162 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Imaging Services, Inc. devices

Submission Details

510(k) Number K010772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2001
Decision Date August 23, 2001
Days to Decision 162 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
55d slower than avg
Panel avg: 107d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

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