FDA.reportPublic FDA data

IMAGE DIAGNOSTICS INC

Primary DI
00850061871008
Brand
IMAGE DIAGNOSTICS INC
Company
IMAGE DIAGNOSTICS, INC.
Model
100-4T G3
Catalog number
A100-3891
Device description
IDI,TABLE,VERT.-TILT-HORIZ. TABLETOP MOVEMENT,VASCULAR-INTERVENTIONAL-IMAGING,ASPECT 100-4T,120V-230V, 24in x 84in TABLETOP WITH FULL LENGTH RAILS,METRIC ACC'Y RAILS,#A100-3891
Published
2024-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00850061871008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850061871008008500618710088500618710080850061871008

GMDN Terms#

Term, Definition table
TermDefinition
Basic diagnostic x-ray system table, poweredA powered/programmable table that is a component of a basic diagnostic x-ray system designed to position and support a patient during a variety of routine/planar or speciality diagnostic procedures requiring the use of a diagnostic x-ray system; it is not a planar tomography nor computed tomography (CT) table. It can be a stationary or mobile unit and is made of radiolucent materials with low x-ray attenuation coefficients. It is not intended for use during interventional radiology/surgery.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-978-829-0009RROSSI@IMAGEDIAGNOSTICS.COM

Regulatory Flags#

DUNS number
608235214
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
00850061871213IMAGE DIAGNOSTICS, INCSCATTER GUARD RADIATION SHIELD FOR 22IN WIDE TABLEA610-0922026-02-24
00850061871220IMAGE DIAGNOSTICS, INCSCATTER GUARD RADIATION SHIELD FOR 24IN WIDE TABLEA610-0962026-02-24
00850061871237IMAGE DIAGNOSTICS, INCSCATTER GUARD RADIATION SHIELD FOR 28IN WIDE TABLEA610-1082026-02-24
00850061871459IMAGE DIAGNOSTICS, INCSCATTER GUARD RADIATION SHIELD FOR ISO-DRIVE FACIAA610-4072026-02-24
00850061871398IMAGE DIAGNOSTICS, INCARTICULATING RADIATION SHIELD FOR U.S. ACCY RAILSA610-0512026-01-30
00850061871404IMAGE DIAGNOSTICS, INCARTICULATING RADIATION SHIELD FOR METRIC ACCY RAILA610-1062026-01-30
00850061871411IMAGE DIAGNOSTICS, INCFIXED RADIATION SHIELD FOR TABLE TOP MOUNTA610-0802026-01-30
00850061871442IMAGE DIAGNOSTICS, INCProtego AFCM System for Philips Tables & SKYTRON bA800-0532-PH012026-01-20
00850061871381IMAGE DIAGNOSTICS, INCProtego Mobile BarrierA800-01552025-12-09
00850061871152IMAGE DIAGNOSTICS, INCProtego FCM System for Philips TablesA800-0250-PH012025-04-07
00850061871374IMAGE DIAGNOSTICS INCMONITOR CART,IDI W/27IN TOUCH MONITOR,GE OEC ONEA280-16272025-11-18
00850061871114IMAGE DIAGNOSTICS, INCUrology Drain Bag, SterileC000-05932025-10-28
00850977007959IMAGE DIAGNOSTICS INC100UC+A100-30992025-08-07
00850061871268IMAGE DIAGNOSTICS, INC.ILEX DUO DIRECT CONNECT 27A280-15672025-07-14
00850061871275IMAGE DIAGNOSTICS, INC.ILEX DUO DIRECT PREMIUM 32A280-15682025-07-14
00850061871282IMAGE DIAGNOSTICS, INC.ILEX DUO PLATINUM 32A280-15692025-07-14
00850061871367IMAGE DIAGNOSTICS, INCCompass Contour Suspended System with 1 ArmA610-0211-1302025-07-07
00850061871299IMAGE DIAGNOSTICS, INCProtego MRS System for GE Table Tops w/Metric AcceA800-0002-GE022025-07-02
00850061871305IMAGE DIAGNOSTICS, INCProtego MRS System for Large Table Tops w/Metric AA800-0004-SAI022025-07-02
00850061871312IMAGE DIAGNOSTICS, INCProtego MRS System for Large Table Tops w/Metric AA800-0004-SII012025-07-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07350006950049Sonesta F3Sonesta Medical ABIXR2025-09-30
00198953043301NAGE Hualun Medical Systems Co., LtdIXR2025-04-22
00850061871015IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-04-03
00850061871022IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-04-03
00850977007997IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-02-23
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00817463026290Oakworks MedicalOAKWORKS, INC.IXR2023-07-10