Cleared Traditional

K073328 - CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA (FDA 510(k) Clearance)

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

K073328 · Paieon, Inc. · Radiology device
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Sep 2008
Decision
287d
Days
Class 2
Risk

K073328 is an FDA 510(k) clearance for the CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Paieon, Inc. (Rosh Haayin, IL). The FDA issued a Cleared decision on September 9, 2008 after a review of 287 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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 Paieon, Inc. devices

Submission Details

510(k) Number K073328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2007
Decision Date September 09, 2008
Days to Decision 287 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
180d slower than avg
Panel avg: 107d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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.

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All 196
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