FDA.reportPublic FDA data

Amirix Imaging

Primary DI
00860013147662
Brand
Amirix Imaging
Company
Amirix Imaging LLC
Model
LM33-T Diagnostic X-Ray Tube
Catalog number
LM33-T
Device description
Diagnostic Mammography X-Ray Tube Assembly
Published
2024-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00860013147662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013147662008600131476628600131476620860013147662

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
119313747
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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