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FDA 510(k)

SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)

K-Number: K080555 · 2008-06-03

ApplicantIvu Imaging Corporation
Decision Date2008-06-03
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS) is the device name listed in this FDA 510(k) record. The listed applicant is Ivu Imaging Corporation. It received FDA 510(k) clearance on 2008-06-03 under 510(k) number K080555. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)?

SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS) is a medical device that received FDA 510(k) clearance on 2008-06-03. The listed applicant is Ivu Imaging Corporation. The 510(k) number is K080555.

When did SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS) receive FDA 510(k) clearance?

SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS) received FDA 510(k) clearance on 2008-06-03, under 510(k) number K080555.

Who is the listed applicant for SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)?

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

What is the FDA product code for SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)?

The FDA product code for SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS) is ITX.

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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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