Image-intensified Fluoroscopic X-ray System, Mobile

Product Code: OXO

Radiology Medical Diagnostic X-Ray Equipment

Definition: Fluoroscopy Of The Human Body.

Applicable Standards: Diagnostic X-ray Systems And Their Major Components. [1020.30] Radiographic Equipment. [1020.31] Fluoroscopic Equipment. [1020.32] Computed Tomography (CT) Equipment. [1020.33]

Code of Federal Regulations: 892.1650


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as OXO

5419Image-intensified Fluoroscopic X-ray System, MobileImage-intensified Fluoroscopic X-ray System.

Total Product Life Cycle (TPLC) Devices

5419Image-intensified Fluoroscopic X-ray System, MobileImage-intensified Fluoroscopic X-ray System.

FDA Consensus Standards

Image-Intensified Fluoroscopic X-Ray System, Mobile [37593]21 CFR §892.1650 🔎
Image-Intensified Fluoroscopic X-Ray System, Mobile [37630]21 CFR §892.1650 🔎
Image-Intensified Fluoroscopic X-Ray System, Mobile [32778]21 CFR §892.1650 🔎
Image-Intensified Fluoroscopic X-Ray System, Mobile [33118]21 CFR §892.1650 🔎

Pre-market Notifications for OXO

K213113Orthoscan Tau Mini C-ArmOrthoscan, Inc.
K203346OEC 3DGE OEC Medical Systems, Inc.
K192819OEC EliteGE OEC Medical Systems, Inc.
K190024Smart-CTurner Imaging Systems, Inc.
K183220OrthoScan TAU Mini C-ArmOrthoscan, Inc.
K182626OEC OneGE Hualun Medical Systems Co., Ltd.
K172550OEC EliteGE OEC Medical Systems, Inc.
K171800OEC Elite MiniViewGE Hualun 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
K163429B6Beijing East Whale Imaging Technology Co., Ltd
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
K151280MultiScan G-Arm SystemBEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD.
K141672DIGIARC 100AU+BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD.

Global Unique Device Identification Database

00643169980976Image-intensified fluoroscopic x-ray system, mobile
00643169845091Image-intensified fluoroscopic x-ray system, mobile
00643169589292Image-intensified fluoroscopic x-ray system, mobile
00643169353428Image-intensified fluoroscopic x-ray system, mobile
00763000132378Image-intensified fluoroscopic x-ray system, mobile
00763000068066Image-intensified fluoroscopic x-ray system, mobile
06970528550018Image-Intensified Fluoroscopic X-Ray System, Mobile
04056869153506Image-intensified fluoroscopic x-ray system, mobile
04056869028132Image-intensified fluoroscopic x-ray system, mobile
04056869009056Image-intensified fluoroscopic x-ray system, mobile
04056869009049Image-intensified fluoroscopic x-ray system, mobile
04056869009032Image-intensified fluoroscopic x-ray system, mobile
04056869009025Image-intensified fluoroscopic x-ray system, mobile
04056869009018Image-intensified fluoroscopic x-ray system, mobile
04056869009001Image-intensified fluoroscopic x-ray system, mobile

Maude Adverse Events

O-ARMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-31
O-ARMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-31
PRGM BI75000022 OARM ADDITIONALMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-31
O-ARMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-30
OARM ASSY BI70000027 SYSTEM PRODUCTMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-30
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-30
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-27
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-27
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-27
BASE OARM BI70000028230 SYS 230VMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-26
O-ARM 1000 IMAGING SYSTEM 3RD EDITIONMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-26
BASE OARM BI70000028120 SYS 120VMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-26
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-25
O-ARMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-25
O-ARM 1000 IMAGING SYSTEM 3RD EDITIONMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-25
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-24
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-24
O-ARM 1000 IMAGING SYSTEM THIRD EDITIONMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-24
O1IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILEMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-24
O-ARM 1000MEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-23
O1IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILEMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-23
O1IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILEMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-23
O-ARM 1000MEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-20
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-20
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-20
O-ARM 1000 IMAGING SYSTEM 3RD EDITIONMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-18
O-ARM 1000 IMAGING SYSTEM 3RD EDITIONMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-18
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-16
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-16
O-ARM 1000MEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-13
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-13
O-ARMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-13
BASE OARM BI70000028230 SYS 230VMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-13
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-13
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-12
O-ARM 1000 IMAGING SYSTEM 3RD EDITIONMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-12
OARM 1000 3RD EDITIONMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-12
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-10
O-ARM 1000 IMAGING SYSTEM 3RD EDITIONMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-10
O1IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILEMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-10
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-10
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-10
O-ARM 1000 3RD EDITIONMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-09
O-ARM SYSTEM 100VMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-09
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-09
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-09
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-09
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-09
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-09
O-ARM 1000 IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2020-03-06

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.