Cleared Traditional

K924922 - CVIS INSIGHT IMAGING CATHETER (FDA 510(k) Clearance)

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

K924922 · Cardiovascular Imaging Systems, Inc. · Radiology device
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Jun 1993
Decision
330d
Days
Class 2
Risk

K924922 is an FDA 510(k) clearance for the CVIS INSIGHT IMAGING CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cardiovascular Imaging Systems, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 29, 1993 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.1200 - 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 Cardiovascular Imaging Systems, Inc. devices

Submission Details

510(k) Number K924922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1992
Decision Date June 29, 1993
Days to Decision 330 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
223d slower than avg
Panel avg: 107d · This submission: 330d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 498
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