FDA.reportPublic FDA data

3D Imaging C-Arm Table

Primary DI
00718175000205
Brand
3D Imaging C-Arm Table
Company
BIODEX MEDICAL SYSTEMS, INC.
Model
058-820
Catalog number
058-820
Device description
Table, 3-D Imaging C-Arm , 115 VAC
Published
2017-12-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IXRTable, Radiographic, Tilting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXRTable, Radiographic, TiltingRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00718175000205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00718175000205007181750002057181750002050718175000205

GMDN Terms#

Term, Definition table
TermDefinition
Fluoroscopy/angiography table, poweredA powered table designed to support and position a patient during fluoroscopy/angiography typically in conjunction with a cardiovascular intervention or other minimally-invasive surgical intervention (e.g., biopsy). It has a flat table top with electronic controls for table top positioning and/or motion relative to the x-ray beam. It is not dedicated to breast biopsy, and is not intended for other specialized surgeries (i.e., it is not a specialized operating table with x-ray transparent features).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
043833813
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
00718175003381SHARPS CONTAINER SHIELD 039-350039-3502019-05-31
00718175003657Neck Phantom 043-365043-3652018-02-15
00718175005002Xenon Rebreathing System 132-680132-6802019-09-30
00718175005019Xenon Rebreathing System 132-681132-6812019-10-16
00718175005040Xenon Rebreathing System 132-690132-6902019-10-16
00718175005057Xenon Rebreathing System 132-691132-6912019-10-16
00718175005064Xenon Rebreathing System 132-692132-6922019-10-16
00718175005071Xenon Rebreathing System 132-699132-6992019-10-16
00718175005088Xenon Rebreathing System 132-770132-7702019-10-16
00718175005101Xenon Rebreathing System 132-774132-7742019-10-17
00718175005125Xenon Rebreathing System 132-784132-7842019-10-16
00718175005132Xenon Rebreathing System 132-793132-7932019-10-16
00718175005149Xenon Rebreathing System 132-771132-7712019-10-16
00718175005156VENTI-SCAN IV177-075177-0752019-12-13
00718175005163AIR CUSHIONED FACE MASK132-685132-6852019-12-13
00718175005170AIR CUSHIONED FACE MASK132-695132-6952019-12-13
00718175005187AIR CUSHIONED FACE MASK132-698132-6982019-12-13
00718175005200BACTERIAL FILTER132-750132-7502019-12-13
00718175005248XENON CONVENIENCE KITS 134-772134-7722019-12-13
00718175002902LEAD LINED 244-157244-1572020-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07350006950049Sonesta F3Sonesta Medical ABIXR2025-09-30
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00850061871008IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-02-23
00850977007997IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-02-23
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