FDA.reportPublic FDA data

Rotating Anode X-ray Tube Assembly

Primary DI
04580274412366
Brand
Rotating Anode X-ray Tube Assembly
Company
CANON ELECTRON TUBES & DEVICES CO. LTD.
Model
XRR-4633FD
Device description
Diagnostic X-ray Tube Housing Assembly
Published
2025-03-14
Public version status
New
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
04580274412366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580274412366045802744123664580274412366

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
696985530
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04580274412397Rotating Anode X-ray Tube AssemblyCXB-750W2025-06-16
04580274412373Rotating Anode X-ray Tube AssemblyXRR-4633XD2025-03-14
04580274413776Rotating Anode X-ray Tube AssemblyXRV-T4941X2024-11-26
04580274413752Rotating Anode X-ray Tube AssemblyXRR-4632XD2024-07-09
04580274413707Rotating Anode X-ray Tube AssemblyE7864XX2024-06-25
04580274412335Rotating Anode X-ray Tube AssemblyCXB-750V2023-04-26
04580274412328Rotating Anode X-ray Tube AssemblyCXB-500C2023-01-26
04580274410119Rotating Anode X-ray Tube AssemblyDRX-1603B2021-08-18
04580274410126Rotating Anode X-ray Tube AssemblyDRX-1615B2021-08-18
04580274413783Rotating Anode X-ray Tube AssemblyXRR-3331X2021-07-07
04580274412311Rotating Anode X-ray Tube AssemblyDSRX-T7735GFS2021-04-20
04580274412281Rotating Anode X-ray Tube AssemblyDSRX-T7634GFS2020-12-25
04580274412298Rotating Anode X-ray Tube AssemblyLX-63082020-12-25
04580274412304Rotating Anode X-ray Tube AssemblyLX-63112020-12-25
04580274413851Rotating Anode X-ray Tube AssemblyXRR-3334F2020-01-23
04580274413868Rotating Anode X-ray Tube AssemblyXRR-3332X2020-01-23
04580274413875Rotating Anode X-ray Tube AssemblyXRR-4631G2020-01-23
04580274413905Rotating Anode X-ray Tube AssemblyE7869XZ2020-01-23
04580274413998Rotating Anode X-ray Tube AssemblyCXB-400C2020-01-23
04580274414001Rotating Anode X-ray Tube AssemblyDSRX-T7444GDS2020-01-23

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
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
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