# K980851: Galaxy Intravascular Ultrasound System, Model I5028

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Apr 22, 1998 after 48 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: 1 generation back to K921750 (1992). 3 ancestors in all.
83 later devices descend from it; 7 cite it directly.
2 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921750: Cvis Insight Iii System, Cardiovascular Imaging Systems, Inc. (1992) Summary page 1.
- K933517: Automatic Pull Back Device, Cardiovascular Imaging Systems, Inc. (1993) Summary page 1.
- K930311: Cvis Longview, Cardiovascular Imaging Systems, Inc. (1993) Summary page 1.
- (no number) EndoSonics In-Vision: named in the summary without a submission number

## Most influential descendants
- 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
- K123535: Ilab Ultrasound Imaging System (2013), 27 descendants of its own

## Indications for use
The Galaxy Intravascular Ultrasound Imaging System is intended for ultrasound examination of intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.

Source page: https://510kreport.com/device/K980851
Methodology: https://510kreport.com/methodology