FDA.reportPublic FDA data

IMAGE DIAGNOSTICS, INC

Primary DI
00850061871190
Brand
IMAGE DIAGNOSTICS, INC
Company
IMAGE DIAGNOSTICS, INC.
Model
Protego ProLite System for Siemens Icono Tables
Catalog number
A800-0471-SII
Device description
IDI,RADIATION SHIELD SYSTEM,PROTEGO,PROLITE TABLE MOUNT,METRIC ACCESSORY RAILS,SIEMENS ICONO TABLE#A800-0471-SII
Published
2025-04-29
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
IWQCurtain, Protective, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWQCurtain, Protective, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850061871190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850061871190008500618711908500618711900850061871190

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding curtainA flexible radiation protective device intended to shield the operator or other attending persons from unnecessary exposure to radiation emitted during a medical or dental procedure. The curtain is a flexible radiation blocking or attenuating barrier located between the individual and the source of primary or scattered radiation. This radiation barrier is designed to hang from rods or tracks attached to the ceiling, wall, radiation delivery equipment, or other radiation shields. It typically consists of a fluid resistant outer covering that surrounds a thin sheet of flexible lead (Pb) or lead-equivalent material.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
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
00850061871169IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.IWQ2025-04-29
00850061871176IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.IWQ2025-04-29
00850061871183IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.IWQ2025-04-29
00850061871206IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.IWQ2025-04-29
00840348525564AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525571AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525588AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525595AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525601AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525618AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525625AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525670AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525687AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525717AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525724AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525731AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525748AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525755AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525786AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525793AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525809AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525816AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525823AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525830AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525847AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525854AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525861AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525878AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525885AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525892AADCOAADCO MEDICAL, INC.IWQ2022-12-19