# K921750: Cvis Insight Iii System

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Imaging Systems, Inc.
- Decided: Jul 13, 1992 after 91 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.
88 later devices descend from it; 3 cite it directly.
2 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K980851: Galaxy Intravascular Ultrasound System, Model I5028 (1998), 83 descendants of its own
- K051679: Ilab Ultrasound Imaging System (2005), 36 descendants of its own
- K052348: IN Vision Gold with Spin Vision, Model 891 SV (2005), 29 descendants of its own
- K071554: Volcano S5/S5I Intravascular Imaging and Pressure System (2008), 28 descendants of its own
- K072517: Ilab Ultrasound Imaging System, Version 1.3 (2007), 28 descendants of its own

Source page: https://510kreport.com/device/K921750
Methodology: https://510kreport.com/methodology