# K963290: Colorflo Option for the Oracle Invision Intravascular Ultrasonic Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Endosonics Corp.
- Decided: Aug 6, 1997 after 350 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.
649 later devices descend from it; 5 cite it directly.
6 of 650 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Endosonic Cathscanner III Intravascular Imaging System: named in the summary without a submission number
- (no number) Endosonics Visions Five 64 3.5F model 84700 Intravascular Imaging Catheter: named in the summary without a submission number
- (no number) Endosonics Visions Five 64 F/X Model 82700 Intravascular Imaging Catheter: named in the summary without a submission number
- (no number) Endosonics Visions Microrail catheters: named in the summary without a submission number
- (no number) Visions Model 54700 catheters: named in the summary without a submission number
- (no number) Cathscanner II Imaging System: named in the summary without a submission number
- (no number) Cathscanner III Imaging System: named in the summary without a submission number
- (no number) Millar Mikro-Tip Doppler Catheter Model DC-101: named in the summary without a submission number
- (no number) Small Vessel Balloon Angioplasty Catheter: named in the summary without a submission number
- (no number) ATL Ultramark 8 Ultrasound Imaging System: named in the summary without a submission number
- (no number) CVIS Insight System: named in the summary without a submission number
- (no number) Platinum System with the CVI Option: named in the summary without a submission number

## 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

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: This system is indicated for intra-luminal use in both peripheral and coronary applications. There is no difference in operation on acoustic outputs when used for coronary or peripheral vascular imaging. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: This system is indicated for intra-luminal use in both peripheral and coronary applications. There is no difference in operation on acoustic outputs when used for coronary or peripheral vascular imaging.

Source page: https://510kreport.com/device/K963290
Methodology: https://510kreport.com/methodology