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FDA 510(k)

VUE 100 ULTRASOUND IMAGING SYSTEM

K-Number: K040652 · 2004-05-17

Decision Date2004-05-17
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VUE 100 ULTRASOUND IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mobilsonic, Inc.. It received FDA 510(k) clearance on 2004-05-17 under 510(k) number K040652. 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 VUE 100 ULTRASOUND IMAGING SYSTEM?

VUE 100 ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2004-05-17. The listed applicant is Mobilsonic, Inc.. The 510(k) number is K040652.

When did VUE 100 ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

VUE 100 ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 2004-05-17, under 510(k) number K040652.

Who is the listed applicant for VUE 100 ULTRASOUND IMAGING SYSTEM?

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

What is the FDA product code for VUE 100 ULTRASOUND IMAGING SYSTEM?

The FDA product code for VUE 100 ULTRASOUND IMAGING SYSTEM 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.

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.

Official Source

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

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