FDA.reportPublic FDA data

IMAGE DIAGNOSTICS, INC

Primary DI
00850061871305
Brand
IMAGE DIAGNOSTICS, INC
Company
IMAGE DIAGNOSTICS, INC.
Model
Protego MRS System for Large Table Tops w/Metric A
Catalog number
A800-0004-SAI02
Device description
IDI,RADIATION SHIELD SYSTEM,PROTEGO,MOBILE,METRIC ACCESSORY RAILS,SIEMENS ARTIS,ARTICULATING RADIATION SHIELD#A800-0004-SAI02
Published
2025-07-02
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
IWXBarrier, Control Panel, X-Ray, Movable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWXBarrier, Control Panel, X-Ray, MovableRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850061871305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850061871305008500618713058500618713050850061871305

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding panel, portable/mobileA portable or mobile rigid barrier designed to shield patients and healthcare professionals from unnecessary exposure to radiation used in diagnostic or therapeutic medical procedures. It provides a physical radiation-attenuating barrier between an individual and a source of primary or scattered radiation. It may be a stand-alone device or intended to be integrated within an electronic system; the panel itself is not electronic. The types of materials used depend on the type of radiation to be attenuated [e.g., those used in diagnostic x-ray and nuclear medicine consist of lead (Pb) or lead-equivalent materials, and those used to attenuate neutrons are composed of hydrogenous materials].

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
00850061871312IMAGE DIAGNOSTICS, INCProtego MRS System for Large Table Tops w/Metric AA800-0004-SII012025-07-02
00850061871329IMAGE DIAGNOSTICS, INCProtego MRS System for Large Table Tops w/Metric AA800-0004-SII022025-07-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00814907020579ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020593ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
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00814907020463ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00814907020500ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00814907020555ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00811870037788Manus Medical, LLCManus Medical, LLCIWX2023-11-08
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G242LPSH36369Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSH48489Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSS24249Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSS24369Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSS24489Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPST2424S9Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPST2430S9Techno-AideTechno-Aide, Inc.IWX2023-10-20
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