FDA.reportPublic FDA data

NA

Primary DI
08800019200000
Brand
NA
Company
ECOTRON
Model
EPX-F1600
Catalog number
ECO-ER-CAT-001P
Device description
Input Power: 110V~120V, 50/60HzOutput Power: 1.6kWKVP range: 40~90kVmA range: 12~30mAmAs range: 0.4~32mAsX-ray Tube: D-125Focal Sport: 1.2 x 1.2mmTarget Angle: 16 degreesAnode heat storage: 50kHU
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IZLSystem, X-Ray, Mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZLSystem, X-Ray, MobileRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800019200000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800019200000088000192000008800019200000

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray system generator, portableAn x-ray generator with special size, weight, and power requirements that makes it suitable for use in a portable x-ray system, e.g., a system intended to be easily disassembled and reassembled at various locations. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). This GMDN code includes transformer and inverter generator designs. Portable x-ray generators typically comprise a control assembly (console) and high voltage transformer assembly or are of a mono-tank generator design.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height190Millimeter
Length355Millimeter
Weight13Kilogram
Width200Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity35 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius60 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
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
08800019200260NAAnyview-320DRECO-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800011150129DRGEMDRGEM CorporationIZL2026-05-20
08800011150136DRGEMDRGEM CorporationIZL2026-05-20
07350011170005TrueMobileSolutions For Tomorrow ABIZL2026-05-18
08800184900002X-RAYNEUF Inc.IZL2026-05-11
08800184900019X-RAYNEUF Inc.IZL2026-05-11
08908021109097PRORAD ATLAS ULTRAPORTABLEPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDIZL2026-05-07
08908021109103PRORAD ATLAS ULTRAPORTABLE PLUSPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDIZL2026-04-16
08800040900108Diagnostic X-ray UnitPoskom Co., Ltd.IZL2026-04-15
08800040900221Airbile-100Poskom Co., Ltd.IZL2026-04-15
08800040900245AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900252AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900269AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900276AirRay-miniPoskom Co., Ltd.IZL2026-04-15
00850079606043MC2 Portable X-ray SystemOXOS Medical, Inc.IZL2026-03-25
00850079606050EmitterOXOS Medical, Inc.IZL2026-03-25
04547410571134FDR AQROFUJIFILM CORPORATIONIZL2026-03-20
00858340006479Del Medical, Inc.Del Medical, Inc.IZL2026-03-05
08800060100229REMEX Xcam6REMEDI CO.,LTD.IZL2026-01-22
04056869297309MOBILETT ImpactSiemens Healthcare GmbHIZL2025-11-20
08800011150105DRGEMDRGEM CorporationIZL2025-08-26
08800011150112DRGEMDRGEM CorporationIZL2025-08-26
08800070400074HnX-P1H&abyz Co., LtdIZL2025-08-12
08800070400166HnX-PBH&abyz Co., LtdIZL2025-08-12
08436046003651SEDECALSEDECALIZL2025-03-21
08436046003668SEDECALSEDECALIZL2025-03-21
08436046003675SEDECALSEDECALIZL2025-03-21
08436046003682SEDECALSEDECALIZL2025-03-21
08436046003699SEDECALSEDECALIZL2025-03-21
08436046003705SEDECALSEDECALIZL2025-03-21
08436046003712SEDECALSEDECALIZL2025-03-21