FDA.reportPublic FDA data

NA

Primary DI
08800019200260
Brand
NA
Company
ECOTRON
Model
Anyview-320DR
Catalog number
ECO-ER-CAT-001DR
Device description
1. Line Voltage: 220~230V, 50/60Hz2. Output Power: 3.2kW3. Fluoroscopy Mode - F-mode: 0.5~10mA - P-mode: 0.5~20mA - Boost mode: 30mA - DS mode: 10~30mA4. Radiography Mode - kV range: 40~110kV, mA range: 15~40mA, mAs range: 0.8~100mAs5. X-ray Tube - XRR-2551(Rotating Type), Focal Spot: 0.3/0.6, Target Angle: 10degree, Anode Heat Storage: 210kHU6. Detector - VIVIX-D 1212G (VIEWORKS), 12 x 12 inch
Published
2018-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified
OWBInterventional Fluoroscopic X-Ray System
OXOImage-Intensified Fluoroscopic X-Ray System, Mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2
OXOImage-Intensified Fluoroscopic X-Ray System, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180473000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180473000ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DREcotron Co., Ltd.2018-03-23OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800019200260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800019200260088000192002608800019200260

GMDN Terms#

Term, Definition table
TermDefinition
Mobile general-purpose fluoroscopic x-ray system, digitalA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height1650Millimeter
Length1852Millimeter
Weight250Kilogram
Width800Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius70 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
9999999999jun1117@ecotron.co.kr

Regulatory Flags#

DUNS number
688209954
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800019200437N/AProX GoECO-ER-CAT-001Pro2025-03-14
08800019200406N/ADT-703ECO-ER-CAT-001DT2022-07-05
08800019200000NAEPX-F1600ECO-ER-CAT-001P2016-09-28
08800019200017NAEPX-F2400ECO-ER-CAT-001P2016-09-28
08800019200024NAEPX-F2800ECO-ER-CAT-001P2016-09-28
08800019200031NAEPX-F3200ECO-ER-CAT-001P2016-09-28
08800019200048NAEPX-F4000ECO-ER-CAT-001P2016-09-28
08800019200055NAEPX-F5000ECO-ER-CAT-001P2016-09-28
08800019200093NAAnyview-500RECO-ER-CAT-002C2016-11-05
08800019200253NAAnyview-240DRECO-ER-CAT-001DR2018-03-29
08800019200277NAAnyview-500DRECO-ER-CAT-001DR2018-03-29
08800019200123N/ASXG-32RECO-ER-CAT-001S2016-10-27
08800019200130N/ASXG-40RECO-ER-CAT-001S2016-10-27
08800019200147N/ASXG-52RECO-ER-CAT-001S2016-10-27
08800019200154N/ASXG-68RECO-ER-CAT-001S2016-10-27
08800019200161N/ASXG-80RECO-ER-CAT-001S2016-10-27

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