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FDA 510(k)

XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5

K-Number: K232526 · 2023-09-12

ApplicantCanon Medical Systems Corporation
Decision Date2023-09-12
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2023-09-12 under approval number K232526. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5?

XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 is a medical device that received FDA 510(k) clearance on 2023-09-12. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K232526.

When was XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 approved by the FDA?

XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 received FDA 510(k) clearance on 2023-09-12, under approval number K232526.

What company makes XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5?

XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5?

The FDA product code for XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 is JAA.

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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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