Cleared Traditional

VIEWCATH 3-D CATHETER PULLBACK (K971397) - FDA 510(k) Clearance

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

K971397 · Quinton, Inc. · Radiology device
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Aug 1997
Decision
132d
Days
Class 2
Risk

K971397 is an FDA 510(k) clearance for the VIEWCATH 3-D CATHETER PULLBACK. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Quinton, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 25, 1997 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 Quinton, Inc. devices

Submission Details

510(k) Number K971397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1997
Decision Date August 25, 1997
Days to Decision 132 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 107d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - ITX Transducer, Ultrasonic, Diagnostic

All 74
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