FDA 510(k)

OEC 3D

K-Number: K203346 · 2021-03-05

Decision Date2021-03-05

Product CodeOXO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OEC 3D is the device name listed in this FDA 510(k) record. The listed applicant is Ge Oec Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-03-05 under 510(k) 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. The listed applicant is Ge Oec Medical Systems, Inc.. The 510(k) number is K203346.

When did OEC 3D receive FDA 510(k) clearance?

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

Who is the listed applicant for OEC 3D?

The FDA 510(k) record lists Ge Oec Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OEC 3D?

The FDA product code for OEC 3D is OXO.

Other records listing Ge Oec Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233669OEC 3D K192819OEC Elite K172550OEC Elite K171565OEC Elite

Related Devices (Code: OXO)

K253296Digital C-ARM with 3DAllengers Medical Systems Limited K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.K253269OEC One CFDGe Hualun Medical Systems Co. , Ltd.K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)Hefei Chimed Intelligent Machine Co., Ltd.K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc.K243452Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, Inc.

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.