Cleared Traditional

K971397 - VIEWCATH 3-D CATHETER PULLBACK

K971397 is an FDA 510(k) clearance for VIEWCATH 3-D CATHETER PULLBACK, manufactured by Quinton, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K971397 · Quinton, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K971397

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.

ITX Device Classification - Class 2, Special Controls

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 336
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K971397.
TRANSDUCER POSITIONER
K973622 · Protek Medical Products, Inc. · Nov 1997
L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM
K973079 · Acuson Corp. · Nov 1997
NEEDLE GUIDE/GRID
K973362 · Protek Medical Products, Inc. · Oct 1997
DEVMED STEPPING AND STABILIZING SYSTEM
K972152 · Devmed Corp. · Aug 1997
INTRACAVITY NEEDLE GUIDE KIT
K955668 · Arlanda Medicinska Instrument Co. AB · Jul 1997
BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY
K972672 · Barzell-Whitmore Maroon Bells, Inc. · Jul 1997