# K944004: Visions 2.9F Ultrasonic Imaging Catheter (Model 84300)

- Pathway: 510(k) (Traditional)
- Applicant: Endosonics Corp.
- Decided: May 4, 1995 after 261 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
654 later devices descend from it; 5 cite it directly.
6 of 655 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K031148: IN-Vision Imaging System (2003), 648 descendants of its own
- K051920: Volcano S5 Imaging System, Model 804200-001 (2005), 614 descendants of its own
- K061215: Volcano S51 Family of Imaging Systems (2006), 613 descendants of its own
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), 569 descendants of its own

Source page: https://510kreport.com/device/K944004
Methodology: https://510kreport.com/methodology