# K970049: BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath Ultra Imaging Catheter 2.9F/20MHZ/37411/

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Imaging Systems, Inc.
- Decided: Jun 20, 1997 after 165 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
No predicates in its family tree.
1,108 later devices descend from it; 5 cite it directly.
3 of 1,109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BSC, Sunnyvale - MicroView 2.9 F Coronary Imaging Catheter: named in the summary without a submission number
- (no number) BSC, Sunnyvale - MicroRail 3.2F Coronary Imaging Catheter: named in the summary without a submission number
- (no number) BSC, Natick (Medi-tech) - Sonicath 3.5 F Interventional Ultrasound Imaging Catheter: named in the summary without a submission number

## Most influential descendants
- K992631: Acunav Diagnostic Ultrasound Catheter (1999), 1,093 descendants of its own
- K022567: Sequoia Signature II Diagnostic Ultrasound System (2002), 1,069 descendants of its own
- K032114: Sequoia 8.0 Diagnostic Ultrasound System (2003), 1,003 descendants of its own
- K041319: Sequoia Diagnostic Ultrasound System (2004), 988 descendants of its own
- K051139: Acuson Sequoia Diagnostic Ultrasound System (2005), 979 descendants of its own

## Indications for use
The Sonicath Ultra Imaging Catheter is intended for the ultrasound examination of peripheral and coronary intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Source page: https://510kreport.com/device/K970049
Methodology: https://510kreport.com/methodology