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FDA 510(k)

DIAGNOSTIC ULTRASOUND, MODEL 1.0

K-Number: K992378 · 1999-09-29

ApplicantVolumetrics Medical Imaging, Inc.
Decision Date1999-09-29
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIAGNOSTIC ULTRASOUND, MODEL 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Volumetrics Medical Imaging, Inc.. It received FDA 510(k) clearance on 1999-09-29 under 510(k) number K992378. 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 DIAGNOSTIC ULTRASOUND, MODEL 1.0?

DIAGNOSTIC ULTRASOUND, MODEL 1.0 is a medical device that received FDA 510(k) clearance on 1999-09-29. The listed applicant is Volumetrics Medical Imaging, Inc.. The 510(k) number is K992378.

When did DIAGNOSTIC ULTRASOUND, MODEL 1.0 receive FDA 510(k) clearance?

DIAGNOSTIC ULTRASOUND, MODEL 1.0 received FDA 510(k) clearance on 1999-09-29, under 510(k) number K992378.

Who is the listed applicant for DIAGNOSTIC ULTRASOUND, MODEL 1.0?

The FDA 510(k) record lists Volumetrics Medical Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIAGNOSTIC ULTRASOUND, MODEL 1.0?

The FDA product code for DIAGNOSTIC ULTRASOUND, MODEL 1.0 is IYO.

Related Clinical Trials

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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Other records listing Volumetrics Medical Imaging, Inc. 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.

K982498DIAGNOSTIC ULTRASOUND SYSTEM

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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