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FDA 510(k)

OEC 3D

K-Number: K203346 · 2021-03-05

ApplicantGe Oec Medical Systems, Inc.
Decision Date2021-03-05
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OEC 3D is a medical device manufactured by Ge Oec Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-03-05 under approval number K203346. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OEC 3D?

OEC 3D is a medical device that received FDA 510(k) clearance on 2021-03-05. It is manufactured by Ge Oec Medical Systems, Inc.. The 510(k) number is K203346.

When was OEC 3D approved by the FDA?

OEC 3D received FDA 510(k) clearance on 2021-03-05, under approval number K203346.

What company makes OEC 3D?

OEC 3D is manufactured by Ge Oec Medical Systems, Inc..

What is the FDA product code for OEC 3D?

The FDA product code for OEC 3D is OXO.

Other Devices by Ge Oec Medical Systems, Inc.

K172550OEC Elite K171565OEC Elite K192819OEC Elite K233669OEC 3D

Related Devices (Code: OXO)

K160984MultiScan G-Arm SystemBeijing East Whale Imaging Technology Co., Ltd. K160131OEC Elite MiniViewGe Hangwei Medical Systems Co., Ltd. K160065GEMSS Medical System Surgical Mobile Fluoroscopic X-ray SystemGemss Medical Systems Co., Ltd. K170946Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V VariantSkanray Technologies Private Limited K172550OEC EliteGe Oec Medical Systems, Inc. K171800OEC Elite MiniViewGe Hualun Medical Systems Co. , Ltd.

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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