Radiology › DiagnosticInterventional Fluoroscopic X-Ray System

Interventional Fluoroscopic X-Ray System

Name: Interventional Fluoroscopic X-Ray System
Brand: Interventional Fluoroscopic X-Ray System

1. Line Voltage: 220~230V, 50/60Hz 2. Output Power: 5kW 3. Fluoroscopy Mode - F-mode: 0.5~10mA - P-mode: 0.5~20mA - Boost mode: 30mA - DS mode: 10~30mA 4. Radiography Mode - kV range:…

Registry build 21.09.26

1. Line Voltage: 220~230V, 50/60Hz 2. Output Power: 5kW 3. Fluoroscopy Mode – F-mode: 0.5~10mA – P-mode: 0.5~20mA – Boost mode: 30mA – DS mode: 10~30mA 4. Radiography Mode – kV range: 40~125kV, mA range: 20~100mA, mAs range: 0.8~200mAs 5. X-ray Tube – XRR-2551(Rotating Type), Focal Spot: 0.3/0.6, Target Angle: 10degree, Anode Heat Storage: 210kHU 6. Image Intensifier – E5830SD-PA4(TOSHIBA), 9inch 7. Camera – CCD, Resolution: 1K X 1K

5manufacturers in China registered for this device type

2catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Beijing (2), Shanghai (2), Guangdong (1).

Chinese manufacturers registered for FDA product code OWB
Manufacturer	City	Province	Registered as	Device types
GE Hangwei Medical Systems Co., Ltd.	Beijing	Beijing	Specification developer	22
GE Healthcare (China) Co., Ltd.	Beijing	Beijing	Specification developer	22
Shanghai United Imaging Healthcare Co., Ltd.	Shanghai	Shanghai	Manufacturer	12
Siemens Shanghai, Medical Equipment Ltd.	Shanghai	Shanghai	Contract manufacturer	10
Siemens Shenzhen Magnetic Resonance Ltd.	Shenzhen	Guangdong	Contract manufacturer	8

Record

Regulatory record for Interventional Fluoroscopic X-Ray System
Listed by	Ecotron Co., Ltd., South Korea
FDA product code	OWB
Device type	Interventional Fluoroscopic X-Ray System
Device class	Class 2
Regulation	21 CFR 892.1650
Establishment	Manufacturer
510(k)	K160279
Record published	2016-11-05
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number
Storage	Storage environment humidity 5 to 95 % RH; Storage environment temperature -10 to 70 °C; Handling environment humidity 30 to 75 % RH; Handling environment temperature 10 to 40 °C
Sizes	Height 1650 to 1783 mm; length 1812 to 1852 mm; width 800 mm; weight 250 kg

Catalogue Numbers

Catalogue numbers for Interventional Fluoroscopic X-Ray System
Catalogue number	Size	Status
Anyview-500R	Height 1783 mm	In distribution
Anyview-320DR	Height 1650 mm	In distribution

Same Product Code

Other products under the same FDA product code
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Azurion	Philips Medical Systems Nederland B.V.	19
LessRay	Nuvasive, Inc.	16
Intelli-C Accessory	Nrt – Nordisk Røntgen Teknik A/S	13
Pulse	Nuvasive, Inc.	12
O-ARM®	Medtronic Navigation, Inc.	11
Genoray	Genoray Co., Ltd.	10
Fujifilm Healthcare Americas Corporation	A.T.S. Applicazione Tecnologie Speciali SRL	7
Fujifilm Medical Systems U.S.A. Inc.	A.T.S. Applicazione Tecnologie Speciali SRL	6
Stephanix	A.T.S. Applicazione Tecnologie Speciali SRL	6

Showing 12 of 122. All products under Interventional Fluoroscopic X-Ray System

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K180473	2018-03-23
K160279	2016-10-14

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.