FDA 510(k)

Infinix INFX-8000V, V6.40

K-Number: K170909 · 2017-06-16

ApplicantToshiba Medical Systems Coroporation

Decision Date2017-06-16

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Infinix INFX-8000V, V6.40 is a medical device manufactured by Toshiba Medical Systems Coroporation. It received FDA 510(k) clearance on 2017-06-16 under approval number K170909. 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 Infinix INFX-8000V, V6.40?

Infinix INFX-8000V, V6.40 is a medical device that received FDA 510(k) clearance on 2017-06-16. It is manufactured by Toshiba Medical Systems Coroporation. The 510(k) number is K170909.

When was Infinix INFX-8000V, V6.40 approved by the FDA?

Infinix INFX-8000V, V6.40 received FDA 510(k) clearance on 2017-06-16, under approval number K170909.

What company makes Infinix INFX-8000V, V6.40?

Infinix INFX-8000V, V6.40 is manufactured by Toshiba Medical Systems Coroporation.

What is the FDA product code for Infinix INFX-8000V, V6.40?

The FDA product code for Infinix INFX-8000V, V6.40 is OWB.

Other Devices by Toshiba Medical Systems Coroporation

K172188Aquilion Prime SP, TSX-303B/1, v8.4

Related Devices (Code: OWB)

K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. K162148Allura Xper R9Philips Medical Systems Nethrlands BV K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. K161976Ziehm Solo FDZiehm Imaging GmbH K161756SyncVision SystemVolcano Corporation

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.