510(k) · Cleared
ClearedViewcath 3-D Catheter Pullback
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quinton, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Aug 25, 1997 as substantially equivalent to K933517 (Cardiovascular Imaging Systems, Inc., 1993) after a 132-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Aug 25, 1997
- Review
- 132 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K933517 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK933517 Automatic Pull Back DeviceCardiovascular Imaging Systems, Inc. · 1993
- This deviceK971397 Viewcath 3-D Catheter PullbackQuinton, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933517 | Automatic Pull Back Device | Cardiovascular Imaging Systems, Inc. | 1993 | — |
| 0 (this device) | K971397 | Viewcath 3-D Catheter Pullback | Quinton, Inc. | 1997 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ITX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K821879 | FDA’s K821879 is Ultrachem T.P. 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…3 Kiel Court Sunnyvale, California 94089 Telephone: (408) 752-8555 Fax: (408) 752-8544 Predicate Device: Cardiovascular Imaging Systems, Inc. Catheter Pullback Device, K821879 and K933517 Description of Device: The ViewCath™ Catheter Pullback is a medical Ultrasound Intravascular transducer catheter pu… | 1982 |
| * | K933517 | Automatic Pull Back DeviceSummary page 1…Sunnyvale, California 94089 Telephone: (408) 752-8555 Fax: (408) 752-8544 Predicate Device: Cardiovascular Imaging Systems, Inc. Catheter Pullback Device, K821879 and K933517 Description of Device: The ViewCath™ Catheter Pullback is a medical Ultrasound Intravascular transducer catheter pullback devic… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K933517.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971397 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971397: Viewcath 3-D Catheter Pullback.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971397
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026