FDA 510(k)

OSCAR (OSCAR Prime, OSCAR Classic)

K-Number: K181943 · 2018-08-17

Decision Date2018-08-17

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OSCAR (OSCAR Prime, OSCAR Classic) is a medical device manufactured by Genoray Co., Ltd.. It received FDA 510(k) clearance on 2018-08-17 under approval number K181943. 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 OSCAR (OSCAR Prime, OSCAR Classic)?

OSCAR (OSCAR Prime, OSCAR Classic) is a medical device that received FDA 510(k) clearance on 2018-08-17. It is manufactured by Genoray Co., Ltd.. The 510(k) number is K181943.

When was OSCAR (OSCAR Prime, OSCAR Classic) approved by the FDA?

OSCAR (OSCAR Prime, OSCAR Classic) received FDA 510(k) clearance on 2018-08-17, under approval number K181943.

What company makes OSCAR (OSCAR Prime, OSCAR Classic)?

OSCAR (OSCAR Prime, OSCAR Classic) is manufactured by Genoray Co., Ltd..

What is the FDA product code for OSCAR (OSCAR Prime, OSCAR Classic)?

The FDA product code for OSCAR (OSCAR Prime, OSCAR Classic) is OWB.

Other Devices by Genoray Co., Ltd.

K172810PORT-X IV K172180OSCAR 15 K200469PAPAYA 3D Premium & PAPAYA 3D Premium Plus K220392PAPAYA 3D & PAPAYA 3D Plus K220423PAPAYA & PAPAYA Plus K211780ZEN-2090 Turbo

View all 13 devices →

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.