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 Type: Ionizing
• Radition Safety: Product
• Annual Reports: Yes

Products Classified as OXO

5419

Image-intensified Fluoroscopic X-ray System, Mobile

Image-intensified Fluoroscopic X-ray System.

Total Product Life Cycle (TPLC) Devices

5419

Image-intensified Fluoroscopic X-ray System, Mobile

Image-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

K213113	Orthoscan Tau Mini C-Arm	Orthoscan, Inc.
K203346	OEC 3D	GE OEC Medical Systems, Inc.
K192819	OEC Elite	GE OEC Medical Systems, Inc.
K190024	Smart-C	Turner Imaging Systems, Inc.
K183220	OrthoScan TAU Mini C-Arm	Orthoscan, Inc.
K182626	OEC One	GE Hualun Medical Systems Co., Ltd.
K172550	OEC Elite	GE OEC Medical Systems, Inc.
K171800	OEC Elite MiniView	GE Hualun Medical Systems Co.Ltd.
K170946	Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant	Skanray Technologies Private Limited
K163429	B6	Beijing East Whale Imaging Technology Co., Ltd
K160984	MultiScan G-Arm System	BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD
K160131	OEC Elite MiniView	GE HANGWEI MEDICAL SYSTEMS CO., LTD.
K160065	GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System	GEMSS MEDICAL SYSTEMS CO., LTD
K151280	MultiScan G-Arm System	BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD.
K141672	DIGIARC 100AU+	BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD.

Global Unique Device Identification Database

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

Maude Adverse Events

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