FDA.reportPublic FDA data

RTM 77 HS

Primary DI
08059307491563
Brand
RTM 77 HS
Company
I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA
Model
0.6/1.25
Device description
Rotating anode X-ray tube for radiography systems
Published
2025-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
08059307491563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059307491563080593074915638059307491563

GMDN Terms#

Term, Definition table
TermDefinition
X-ray system tube rotating anode assemblyA component of an x-ray tube, the rotating anode subassembly provides the means to rotate a disc made of tungsten (W) or an alloy of tungsten at speeds above 3000 revolutions per minute while the x-ray tube is operational. The disc is contained within the vacuum of the glass x-ray tube. The power to effect rotation is provided by a magnetic field produced by stator coils which surround the neck of the x-ray tube outside the glass envelope. This mechanism is used in x-ray tube designs in order to dissipate the heat generated by x-ray tubes and to allow them to withstand the heat generated by large x-ray exposures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
430263475
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08059307491594RTM 780 HS0.3/0.62025-11-14
08059307491358C30C302020-08-24
08059307490009X20 P0.3/0.62020-08-25
08059307490016X220.3/0.62020-08-25
08059307490023X220.6/1.32020-08-25
08059307490030X220.82020-08-25
08059307490047X220.8/1.22020-08-25
08059307490054X220.8/1.32020-08-25
08059307490061X22 HS0.82020-08-25
08059307490078X22 P0.3/0.62020-08-25
08059307490085X22 P0.6/1.32020-08-25
08059307490092RTM 30 HS0.3/0.62020-08-25
08059307490108RTM 30 HS0.3/0.82020-08-25
08059307490115RTM 30 HS0.5/0.82020-08-25
08059307490122RTM 30 HS0.6/1.32020-08-25
08059307490139RTM 30 HS0.8/1.32020-08-25
08059307490146RTM 37 HS0.3/0.62020-08-25
08059307490160X401.0/2.02020-08-25
08059307490184X760.6/1.22020-08-25
08059307490191X40 S1.0/2.02020-08-25

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
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
06977943360277Medical diagnostic rotating anode X-ray tubeBeijing Smartbeam Medical Devices Co.,LTDITY2024-12-13