# Cardiovascular Imaging Systems, Inc.

- Location (FDA's records): Sunnyvale, CA
- FDA decisions: 19 (1989–1997): 19 510(k) clearances
- Product codes: DQO (8), ITX (6), IYO (2), DQX (1), DXK (1), LYK (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 17 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Boston Scientific Corp: 5 (https://510kreport.com/company/boston-scientific)
- Hewlett-Packard Co.: 3 (https://510kreport.com/company/hewlett-packard)
- Indec Systems, Inc.: 3 (https://510kreport.com/company/indec-systems)
- Acuson Corp.: 2 (https://510kreport.com/company/acuson)
- Diasonics, Inc.: 1 (https://510kreport.com/company/diasonics)
- Quinton, Inc.: 1 (https://510kreport.com/company/quinton)
- Softscope Medical Technologies, Inc.: 1 (https://510kreport.com/company/softscope-medical-technologies)
- Boston Scientific, Target: 1 (https://510kreport.com/company/boston-scientific-target)

## Its most-cited devices
- K970049: BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath Ultra Imaging Catheter 2.9F/20MHZ/37411/ (1997), cited by 5
- K933517: Automatic Pull Back Device (1993), cited by 4
- K921750: Cvis Insight Iii System (1992), cited by 3
- K930311: Cvis Longview (1993), cited by 2
- K921148: Cvis Insight Catheters for Intracardiac Use (1992), cited by 1
- K942231: Microview II/Microrail II Catheters (1994), cited by 1

## Recent decisions
- K970049: BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath Ultra Imaging Catheter 2.9F/20MHZ/37411/ (Jun 20, 1997)
- K942231: Microview II/Microrail II Catheters (Aug 1, 1994)
- K933517: Automatic Pull Back Device (Oct 15, 1993)
- K930232: Cvis Insight Imaging Guide Catheter (Jul 21, 1993)
- K924922: Cvis Insight Imaging Catheter (Jun 29, 1993)
- K930311: Cvis Longview (Jun 2, 1993)
- K921879: Cbis Catheter Pull-Back Device (Jul 16, 1992)
- K921750: Cvis Insight Iii System (Jul 13, 1992)

Source page: https://510kreport.com/company/cardiovascular-imaging-systems