# K052348: IN Vision Gold with Spin Vision, Model 891 SV

- Pathway: 510(k) (Traditional)
- Applicant: Volcano Corporation
- Decided: Dec 2, 2005 after 95 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
Longest line of descent: 2 generations back to K921750 (1992). 9 ancestors in all.
29 later devices descend from it; 1 cites it directly.
1 of 39 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031148: IN-Vision Imaging System, Jomed, Inc. (2003) Summary page 1.
- K962293: Endosonics Automatic Pull Back Device, Endosonics Corp. (1996) Summary page 1.
- K980851: Galaxy Intravascular Ultrasound System, Model I5028, Boston Scientific Corp (1998) Summary page 1.

## Most influential descendants
- K071554: Volcano S5/S5I Intravascular Imaging and Pressure System (2008), 28 descendants of its own
- K082229: S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow System (2008), 25 descendants of its own
- K111706: Volcano S5IINTRAVASCULAR Imaging and Pressure System (2011), 24 descendants of its own
- K123898: Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System (2013), 21 descendants of its own
- K133323: Volcano Ifr Modality (2014), 18 descendants of its own

## Indications for use
Qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15cm.

Source page: https://510kreport.com/device/K052348
Methodology: https://510kreport.com/methodology