# K965223: Resolve Option for the Oracle in Vision Intravascular Ultrasonic Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Endosonics Corp.
- Decided: Jun 29, 1998 after 545 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.
650 later devices descend from it; 6 cite it directly.
6 of 651 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) EndoSonics 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) Millar Mikro-Tip Doppler Catheter Model DC-101: named in the summary without a submission number
- (no number) Echo-Scan System: named in the summary without a submission number
- (no number) ATL Ultramark 8 & 9 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) Philips DCI Angiographic Analysis System: named in the summary without a submission number
- (no number) EndoSonics Visions Microrail catheters: named in the summary without a submission number
- (no number) EndoSonics 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) Cook Small Vessel Balloon Angioplasty catheter: named in the summary without a submission number
- (no number) Philips DCI Angiographic analysis system: named in the summary without a submission number
- (no number) CVIS Insight and Ultra Imaging systems and catheters: 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: Intravascular Imaging; Coronary and Peripheral Vascular - all catheters use the same imaging mode.

Source page: https://510kreport.com/device/K965223
Methodology: https://510kreport.com/methodology