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FDA 510(k)

XIDF-AWS801, Angio Workstation, V7.0

K-Number: K172646 · 2017-10-30

Decision Date2017-10-30
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XIDF-AWS801, Angio Workstation, V7.0 is a medical device manufactured by Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2017-10-30 under approval 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. It is manufactured by Toshibamedical Systems Corporation. The 510(k) number is K172646.

When was XIDF-AWS801, Angio Workstation, V7.0 approved by the FDA?

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

What company makes XIDF-AWS801, Angio Workstation, V7.0?

XIDF-AWS801, Angio Workstation, V7.0 is manufactured by Toshibamedical Systems Corporation.

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

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