FDA.reportPublic FDA data

Radshield screen

Primary DI
00195278620729
Brand
Radshield screen
Company
GE MEDICAL SYSTEMS
Model
MVG1
Device description
RADSHIELD SCREEN
Published
2022-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

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
00195278620729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195278620729001952786207291952786207290195278620729

GMDN Terms#

Term, Definition table
TermDefinition
Stationary mammographic x-ray system, digitalA stationary assembly of devices designed to generate x-ray images of the breast using digital techniques for image capture and display. It is designed specifically to compress the breast during imaging and is intended to visually evaluate the anatomy and function of blood and lymphatic vessels within the breast. Often referred to as a digital mammography system (DMS) it is typically used for breast cancer screening or during biopsy procedures (e.g., placement of biopsy markers, stereotactic biopsy). It is designed to capture two-dimensional (2-D) x-ray images, however may include software intended to process multiple images to create a three-dimensional (3-D) image/model (tomosynthesis).

Regulatory Flags#

DUNS number
266062561
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198953109281Senographe PristinaPOZ22025-12-01
00198953052488AlliaMoveo59818762025-12-17
10198953054311not applicablePRISTINA 2.102025-11-28
00198953076873SenoIris12025-11-24
00840682122603not applicable57276692017-09-13
00840682108621INNOVAIGS 620 0022016-08-01
00840682108638INNOVAIGS 630 0022016-08-01
00840682110129INNOVAIGS 520 0022016-08-01
00840682110648DISCOVERYIGS 730 0022016-08-01
00840682110662INNOVAIGS 530 0022016-08-01
00840682110693DISCOVERYIGS 740 0022016-08-01
00840682110709INNOVAIGS 540 0022016-08-01
00840682124621INNOVAIGS 5 0012018-01-24
00840682124638DISCOVERYIGS 7 0012018-02-11
00840682125888DISCOVERYIGS 7 OR 0012018-02-10
00840682141581INTERACT DiscoveryRT 0012018-06-14
00840682147378INNOVAIGS 3 0012020-02-03
00840682121637INNOVAUPG X100 0012016-09-24
00840682100076SenoClaireLLH25434135-52015-01-22
00840682121064SenoBrightGPE12016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00814907020340ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020562ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020579ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020593ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020609ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020623ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020647ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020654ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020661ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020425ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00814907020432ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
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
G242LPSGS24249Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSGS24369Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSGS24489Techno-AideTechno-Aide, Inc.IWX2023-10-20
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
G242LPST2436S9Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPST2448S9Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPST3030S9Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPST3036S9Techno-AideTechno-Aide, Inc.IWX2023-10-20