FDA 510(k)

Solid State X-ray Imager(Model: FXRD-4386WB)

K-Number: K220239 · 2022-09-13

Decision Date2022-09-13

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Solid State X-ray Imager(Model: FXRD-4386WB) is a medical device manufactured by Vieworks Co., Ltd.. It received FDA 510(k) clearance on 2022-09-13 under approval number K220239. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solid State X-ray Imager(Model: FXRD-4386WB)?

Solid State X-ray Imager(Model: FXRD-4386WB) is a medical device that received FDA 510(k) clearance on 2022-09-13. It is manufactured by Vieworks Co., Ltd.. The 510(k) number is K220239.

When was Solid State X-ray Imager(Model: FXRD-4386WB) approved by the FDA?

Solid State X-ray Imager(Model: FXRD-4386WB) received FDA 510(k) clearance on 2022-09-13, under approval number K220239.

What company makes Solid State X-ray Imager(Model: FXRD-4386WB)?

Solid State X-ray Imager(Model: FXRD-4386WB) is manufactured by Vieworks Co., Ltd..

What is the FDA product code for Solid State X-ray Imager(Model: FXRD-4386WB)?

The FDA product code for Solid State X-ray Imager(Model: FXRD-4386WB) is MQB.

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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.