# K971397: Viewcath 3-D Catheter Pullback

- Pathway: 510(k) (Traditional)
- Applicant: Quinton, Inc.
- Decided: Aug 25, 1997 after 132 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933517 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933517: Automatic Pull Back Device, Cardiovascular Imaging Systems, Inc. (1993) Summary page 1.

## Cited in the summary but kept off the family tree
- K821879: Ultrachem T.P., Harleco Diagnostics (1982). Our OCR of the scanned summary read K821879, FDA’s number for Ultrachem T.P. (Harleco Diagnostics). Its FDA name has none of the distinctive words the summary uses for the device it names, “Cardiovascular Imaging Systems, Inc. Catheter Pullback Device”. Kept off the family tree. Summary page 1.

## Indications for use
The ViewCath™ Catheter Pullback is a device used for motorized pullback of medical Ultrasound intravascular imaging catheters to assist in consistent, selectable speed, 2-D image acquisition for use by medical imaging software for longitudinal view display or 3-D reconstruction and rendering and volumetric presentation of 3-D images for diagnostic review.

Source page: https://510kreport.com/device/K971397
Methodology: https://510kreport.com/methodology