FDA.reportPublic FDA data

Mingwei

Primary DI
26973915530048
Brand
Mingwei
Company
MingWei Medical Technology(Suzhou)Co.,LTD
Model
MWHX7810A
Device description
A metallic case that houses an x-ray tube to provide appropriate limits for x-ray leakage and adequate insulation to avoid electric risks during a diagnostic x-ray procedure. It includes sheet lead surrounds at appropriate locations to shield unwanted x-ray radiation and collimators near the aperture; it is usually filled with oil to prevent electrical arcs from the high-voltage components of the x-ray tube. The housing also includes attachment points, cooling means, high-voltage cables, and supports for the tube and cable receptacles.
Published
2020-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ITYAssembly, Tube Housing, X-Ray, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITYAssembly, Tube Housing, X-Ray, DiagnosticRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26973915530048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2697391553004826973915530048

GMDN Terms#

Term, Definition table
TermDefinition
X-ray tube housing assembly, diagnosticA metallic (e.g., steel, aluminium alloy) case that houses an x-ray tube to provide appropriate limits for x-ray leakage and adequate insulation to avoid electric risks during a diagnostic x-ray procedure. It includes sheet lead surrounds at appropriate locations to shield unwanted x-ray radiation and collimators near the aperture; it is usually filled with oil to prevent electrical arcs from the high-voltage components of the x-ray tube. The housing also includes attachment points, cooling means, high-voltage cables, and supports for the tube and cable receptacles. It may be an independent unit mounted in a tube support, or under a fluoroscopic table as a component of a radiographic system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544042626
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16973915530430MingweiMWTX-A108-0.6/1.0-150H2026-01-16
16973915530393MingweiMWTX-A104-0.6/1.2-150H2024-04-29
16973915530409MingweiMWTX-A71K-0.6/1.5-125S2024-04-29
16973915530416MingweiMWTX-A73-0.6/1.2-150H2024-04-29
16973915530423MingweiMWTX-A70K-1.0/2.0-125S2024-04-29
16973915530379MingweiMWTX-A77K-0.7/1.3-150S2023-12-05
16973915530386MingweiMWTX-A64-0.3/0.6-1252023-12-05
16973915530362MingweiMWTX-A73-0.6/1.2-1502023-11-28
16973915530355MingweiMWTX100-0.6/1.2-150H2023-04-27
16973915530348MingweiMWTX71-0.6/1.5-125S2023-03-21
16973915530331MingweiMWTX71-0.6/1.2-125S2022-08-08
16973915530003MingweiMWTX77-0.7/1.3-1352021-05-07
06973915530006MingweiMWTX77-0.7/1.3-1302021-01-08
16973915530010MingweiMWTX77-0.7/1.3-1302021-01-08
26973915530000MingweiMWTX77-0.7/1.3-1302020-12-30
26973915530017MingweiMWHX7360A2020-12-30
26973915530024MingweiMWHX7420A2020-12-30
26973915530031MingweiMWHX7620A2020-12-30
26973915530055Mingwei MWHX7220A2020-12-30
26973915530062MingweiMWHX7210A2020-12-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16973915530430MingweiMingWei Medical Technology(Suzhou)Co.,LTDITY2026-01-16
10850012223167Chronos Imaging LLCCHRONOS IMAGING LLCITY2025-12-29
00198953042748LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCITY2025-12-05
08059307491563RTM 77 HSI.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPAITY2025-11-14
08059307491594RTM 780 HSI.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPAITY2025-11-14
10850012223136Chronos Imaging LLCCHRONOS IMAGING LLCITY2025-10-31
00195278723963NAGE Healthcare Japan CorporationITY2025-10-15
06971564631563RADIIHangzhou Kailong Medical Instruments Co.,Ltd.ITY2025-08-30
06971564630153RADIIHangzhou Kailong Medical Instruments Co.,Ltd.ITY2025-08-11
06971564630160RADIIHangzhou Kailong Medical Instruments Co.,Ltd.ITY2025-08-11
06971564630214RADIIHangzhou Kailong Medical Instruments Co.,Ltd.ITY2025-08-11
00884838127517CT XS Tube CPOPhilips Medical Systems DMC GmbHITY2025-07-31
04580274412397Rotating Anode X-ray Tube AssemblyCANON ELECTRON TUBES & DEVICES CO. LTD.ITY2025-06-16
06971564631396RADIIHangzhou Kailong Medical Instruments Co.,Ltd.ITY2025-04-24
04580274412366Rotating Anode X-ray Tube AssemblyCANON ELECTRON TUBES & DEVICES CO. LTD.ITY2025-03-14
04580274412373Rotating Anode X-ray Tube AssemblyCANON ELECTRON TUBES & DEVICES CO. LTD.ITY2025-03-14
06971564631198RADIIHangzhou Kailong Medical Instruments Co.,Ltd.ITY2025-01-22
00195278770271VolusonGE Healthcare Austria GmbH & Co OGITY2025-01-07
06977943360154Medical diagnostic rotating anode X-ray tubeBeijing Smartbeam Medical Devices Co.,LTDITY2024-12-13
06977943360161Medical diagnostic rotating anode X-ray tubeBeijing Smartbeam Medical Devices Co.,LTDITY2024-12-13
06977943360178Medical diagnostic rotating anode X-ray tubeBeijing Smartbeam Medical Devices Co.,LTDITY2024-12-13
06977943360185Medical diagnostic rotating anode X-ray tubeBeijing Smartbeam Medical Devices Co.,LTDITY2024-12-13
06977943360192Medical diagnostic rotating anode X-ray tubeBeijing Smartbeam Medical Devices Co.,LTDITY2024-12-13
06977943360208Medical diagnostic rotating anode X-ray tubeBeijing Smartbeam Medical Devices Co.,LTDITY2024-12-13
06977943360215Medical diagnostic rotating anode X-ray tubeBeijing Smartbeam Medical Devices Co.,LTDITY2024-12-13
06977943360222Medical diagnostic rotating anode X-ray tubeBeijing Smartbeam Medical Devices Co.,LTDITY2024-12-13
06977943360239Medical diagnostic rotating anode X-ray tubeBeijing Smartbeam Medical Devices Co.,LTDITY2024-12-13
06977943360246Medical diagnostic rotating anode X-ray tubeBeijing Smartbeam Medical Devices Co.,LTDITY2024-12-13
06977943360253Medical diagnostic rotating anode X-ray tubeBeijing Smartbeam Medical Devices Co.,LTDITY2024-12-13
06977943360260Medical diagnostic rotating anode X-ray tubeBeijing Smartbeam Medical Devices Co.,LTDITY2024-12-13