DEVICE: NA (08800019200253)

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Device Record History
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Device Identifier (DI) Information
NA
Anyview-240DR
In Commercial Distribution
ECO-ER-CAT-001DR
ECOTRON
08800019200253
GS1

1
688209954 *Terms of Use
1. Line Voltage: 220~230V, 50/60Hz 2. Output Power: 2.4kW 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: 40~110kV, mA range: 16~30mA, mAs range: 0.8~100mAs 5. X-ray Tube - XRR-2551(Rotating Type), Focal Spot: 0.3/0.6, Target Angle: 10degree, Anode Heat Storage: 210kHU 6. Detector - VIVIX-D 1212G (VIEWORKS), 12 x 12 inch
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
37646 Mobile general-purpose fluoroscopic x-ray system, digital
A mobile (within an imaging facility) general-purpose diagnostic fluoroscopic x-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be both real-time and delayed formats.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
JAA System, X-Ray, Fluoroscopic, Image-Intensified
OWB Interventional Fluoroscopic X-Ray System
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K180473 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 70 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
Weight: 250 Kilogram
Width: 800 Millimeter
Length: 1852 Millimeter
Height: 1650 Millimeter
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Device Record Status
2b994469-d7aa-4454-886a-6c7928b92007
July 06, 2018
2
March 29, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
9999999999
jun1117@ecotron.co.kr
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