FDA.reportPublic FDA data

SMARTBEAM

Primary DI
06976299950279
Brand
SMARTBEAM
Company
Beijing Smartbeam Technology Co., LTD
Model
ZS502L/H580C
Published
2023-06-06
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
06976299950279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976299950279069762999502796976299950279

GMDN Terms#

Term, Definition table
TermDefinition
X-ray system tubeA replaceable component of a medical or dental diagnostic, or therapeutic x-ray system consisting of a tube (a glass envelope enclosing a filament, anode, cathode under vacuum, and an interface for an electrical connection) designed to convert an input of electrical energy into an output of x-ray energy. It is the x-ray system component that provides a supply of electrons which are free to move, a means of getting the electrons to travel at high-speed, and providing a force which will cause them to suddenly change direction which results in x-ray production. Included are designs referred to as cold-cathode gas discharge tubes, fixed anode tubes, rotating anode tubes, quick change tubes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
706528439
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976299950149SMARTBEAMZS302B/H580B2023-06-06
06976299950156SMARTBEAMZS352B/H498A2023-06-06
06976299950163SMARTBEAMZS352C/H485A2023-06-06
06976299950170SMARTBEAMZS402L/H493A2023-06-06
06976299950187SMARTBEAMZS502B/H590A2023-06-06
06976299950194SMARTBEAMZS502L/H580A2023-06-06
06976299950200SMARTBEAMZS602L/H560B2023-06-06
06976299950217SMARTBEAMZS632B/H847A2023-06-06
06976299950224SMARTBEAMZS702L/H847B2023-06-06
06976299950231SMARTBEAMZS712L/H485B2023-06-06
06976299950248SMARTBEAMZS752B/H425A2023-06-06
06976299950255SMARTBEAMZS802B/H601A2023-06-06
06976299950262SMARTBEAMZS802L/H560A2023-06-06
16976299950016SMARTBEAMZS302B2023-06-06
16976299950023SMARTBEAMZS352B2023-06-06
16976299950030SMARTBEAMZS352C2023-06-06
16976299950047SMARTBEAMZS402L2023-06-06
16976299950054SMARTBEAMZS502B2023-06-06
16976299950061SMARTBEAMZS502L2023-06-06
16976299950078SMARTBEAMZS602L2023-06-06

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