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FDA 510(k)

XIDF-AWS801, Angio Workstation, V7.0

K-Number: K172646 · 2017-10-30

ApplicantToshibamedical Systems Corporation
Decision Date2017-10-30
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XIDF-AWS801, Angio Workstation, V7.0 is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2017-10-30 under 510(k) number K172646. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XIDF-AWS801, Angio Workstation, V7.0?

XIDF-AWS801, Angio Workstation, V7.0 is a medical device that received FDA 510(k) clearance on 2017-10-30. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K172646.

When did XIDF-AWS801, Angio Workstation, V7.0 receive FDA 510(k) clearance?

XIDF-AWS801, Angio Workstation, V7.0 received FDA 510(k) clearance on 2017-10-30, under 510(k) number K172646.

Who is the listed applicant for XIDF-AWS801, Angio Workstation, V7.0?

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

What is the FDA product code for XIDF-AWS801, Angio Workstation, V7.0?

The FDA product code for XIDF-AWS801, Angio Workstation, V7.0 is OWB.

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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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