FDA 510(k)

XPLUS 35 Series (XPLUS 35, XPLUS 35FD)

K-Number: K233200 · 2023-11-16

Decision Date2023-11-16

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

XPLUS 35 Series (XPLUS 35, XPLUS 35FD) is a medical device manufactured by GEMSS HEALTHCARE CO., LTD.. It received FDA 510(k) clearance on 2023-11-16 under approval number K233200. 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 XPLUS 35 Series (XPLUS 35, XPLUS 35FD)?

XPLUS 35 Series (XPLUS 35, XPLUS 35FD) is a medical device that received FDA 510(k) clearance on 2023-11-16. It is manufactured by GEMSS HEALTHCARE CO., LTD.. The 510(k) number is K233200.

When was XPLUS 35 Series (XPLUS 35, XPLUS 35FD) approved by the FDA?

XPLUS 35 Series (XPLUS 35, XPLUS 35FD) received FDA 510(k) clearance on 2023-11-16, under approval number K233200.

What company makes XPLUS 35 Series (XPLUS 35, XPLUS 35FD)?

XPLUS 35 Series (XPLUS 35, XPLUS 35FD) is manufactured by GEMSS HEALTHCARE CO., LTD..

What is the FDA product code for XPLUS 35 Series (XPLUS 35, XPLUS 35FD)?

The FDA product code for XPLUS 35 Series (XPLUS 35, XPLUS 35FD) is OWB.

Other Devices by GEMSS HEALTHCARE CO., LTD.

K230800XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50

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.