ZEN-2090 Turbo
K-Number: K211780 · 2022-03-09
ApplicantGenoray Co., Ltd.
Decision Date2022-03-09
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ZEN-2090 Turbo is a medical device manufactured by Genoray Co., Ltd.. It received FDA 510(k) clearance on 2022-03-09 under approval number K211780. 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 ZEN-2090 Turbo?
ZEN-2090 Turbo is a medical device that received FDA 510(k) clearance on 2022-03-09. It is manufactured by Genoray Co., Ltd.. The 510(k) number is K211780.
When was ZEN-2090 Turbo approved by the FDA?
ZEN-2090 Turbo received FDA 510(k) clearance on 2022-03-09, under approval number K211780.
What company makes ZEN-2090 Turbo?
ZEN-2090 Turbo is manufactured by Genoray Co., Ltd..
What is the FDA product code for ZEN-2090 Turbo?
The FDA product code for ZEN-2090 Turbo is OWB.
Other Devices by Genoray Co., Ltd.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.