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FDA 510(k)

COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM

K-Number: K963290 · 1997-08-06

ApplicantEndosonics Corp.
Decision Date1997-08-06
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Endosonics Corp.. It received FDA 510(k) clearance on 1997-08-06 under 510(k) number K963290. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM?

COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1997-08-06. The listed applicant is Endosonics Corp.. The 510(k) number is K963290.

When did COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM receive FDA 510(k) clearance?

COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM received FDA 510(k) clearance on 1997-08-06, under 510(k) number K963290.

Who is the listed applicant for COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM?

The FDA 510(k) record lists Endosonics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM?

The FDA product code for COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM is IYO.

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Other records listing Endosonics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: IYO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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