Lixiscope - or Lixi

FDA 510(k) K820658 · Lixi, Inc.

Substantially Equivalent

510(k) numberK820658

Submission

Device name
Lixiscope - or Lixi
Applicant
Lixi, Inc.
Walker, MI, US
Received
March 10, 1982
Decision date
May 18, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1650
Specialty
Radiology

Fluoroscopy of the human body.

Other 510(k)s with product code OXO

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K253296Digital C-ARM with 3DOXO · Traditional Allengers Medical Systems Limited06/05/2026SE
K252579Orthoscan TAU MVP Mini C-Arm SystemOXO · Traditional Ziehm-Orthoscan, Inc.01/14/2026SE
K253269OEC One CFDOXO · Traditional Ge Hualun Medical Systems Co. , Ltd.11/26/2025SE
K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)OXO · Traditional Hefei Chimed Intelligent Machine Co., Ltd.11/06/2025SE
K250587Orthoscan TAU Mini C-ArmOXO · Special Ziehm-Orthoscan, Inc.07/02/2025SE
K243452Orthoscan VERSA Mini C-ArmOXO · Traditional Ziehm-Orthoscan, Inc.01/14/2025SE
K240828OEC One ASDOXO · Traditional Ge Hualun Medical Systems Co. , Ltd.12/27/2024SE
K233669Oec 3DOXO · Traditional Ge Oec Medical Systems, Inc.03/28/2024SE
K213113Orthoscan Tau Mini C-ArmOXO · Special Orthoscan, Inc.10/21/2021SE
K203346Oec 3DOXO · Traditional Ge Oec Medical Systems, Inc.03/05/2021SE

More from Ge Oec Medical Systems, Inc.

510(k)DeviceDecision
K925251Lixi Imaging Scope. ModificationJAA · Traditional 12/28/1992SE

Questions and answers

When was Lixiscope - or Lixi cleared by the FDA?

Lixiscope - or Lixi (K820658) received a 510(k) decision of Substantially Equivalent on May 18, 1982, 69 days after the submission was received.

What is the product code of K820658?

The FDA product code is OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1650.