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FDA 510(k)

Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)

K-Number: K221512 · 2022-07-20

ApplicantVieworks Co., Ltd.
Decision Date2022-07-20
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) is a medical device manufactured by Vieworks Co., Ltd.. It received FDA 510(k) clearance on 2022-07-20 under approval number K221512. 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 Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)?

Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) is a medical device that received FDA 510(k) clearance on 2022-07-20. It is manufactured by Vieworks Co., Ltd.. The 510(k) number is K221512.

When was Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) approved by the FDA?

Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) received FDA 510(k) clearance on 2022-07-20, under approval number K221512.

What company makes Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)?

Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) is manufactured by Vieworks Co., Ltd..

What is the FDA product code for Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)?

The FDA product code for Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) is MQB.

Other Devices by Vieworks Co., Ltd.

K161113QXLink K152894VIVIX-S 1717N K152855VIVIX-S 1012N K163703VIVIX-S 1417N K181003VIVIX-S 1717V K190611VIVIX-S 1751S

View all 12 devices →

Related Devices (Code: MQB)

K162555EVS 4343, EVS 4343GDRTECH Corporation K162344INNOLUX RICInnolux Corporation K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai) , Ltd. K162552EVS 3643, EVS 3643GDRTECH Corporation K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, Inc.

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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