# K024103: Ivus Plus

- Pathway: 510(k) (Traditional)
- Applicant: Indec Systems, Inc.
- Decided: Jan 24, 2003 after 43 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965223: Resolve Option for the Oracle in Vision Intravascular Ultrasonic Imaging System, Endosonics Corp. (1998) Summary page 1.
- K980851: Galaxy Intravascular Ultrasound System, Model I5028, Boston Scientific Corp (1998) Summary page 1.
- 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.

## Indications for use
It is indicated for use in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.

Source page: https://510kreport.com/device/K024103
Methodology: https://510kreport.com/methodology