COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM— 510(k) K963290

Substantially Equivalent

Endosonics Corp.

FDA 510(k) clearance K963290 for COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM, Substantially Equivalent on 1997-08-06. Applicant: Endosonics Corp..

Clearance details

Applicant: Endosonics Corp.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1996-08-21
Decision date: 1997-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Cordova, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.