FDA.reportPublic FDA data

Allia

Primary DI
00195278215550
Brand
Allia
Company
GE MEDICAL SYSTEMS
Model
IGS 7 OR 001
Catalog number
5855630
Device description
Allia IGS 7 OR UDI
Published
2021-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IZISystem, x-ray, angiographic
JAASystem, x-ray, fluoroscopic, image-intensified
OWBInterventional fluoroscopic x-ray system
OXOImage-intensified fluoroscopic x-ray system, mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZISystem, X-Ray, AngiographicRadiology2
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2
OXOImage-Intensified Fluoroscopic X-Ray System, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181403000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181403000Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare2018-11-02OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195278215550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195278215550001952782155501952782155500195278215550

GMDN Terms#

Term, Definition table
TermDefinition
Stationary angiographic x-ray system, digitalA stationary diagnostic fluoroscopic x-ray system specifically designed to optimize the capability of users to visually and quantitatively evaluate the anatomy and function of blood vessels of the heart, brain and other organs, as well as the lymphatic system. It uses digital techniques for real-time image capture, display and manipulation and typically includes spot-film capabilities in addition to the fluoroscopic features. It is commonly used in conjunction with an injected x-ray contrast medium during either imaging or x-ray guided surgical or interventional procedures. Images can be viewed in both real-time and delayed formats.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal103 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
266062561
Device count
1
Serial number
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060508110057Cydar MapsCYDAR LIMITEDOWB2026-05-27
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08055186671225A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
08055186671232A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671232A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.JAA2026-04-30
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.OXO2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.JAA2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.OXO2026-04-30
08809365283033SG HealthcareSG Healthcare Co., Ltd.OWB2026-04-24
08809244060533GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060533GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060557GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060557GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060632GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060632GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060601GenorayGENORAY CO., LTD.OWB2025-12-01
08809244060618GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060625GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060700GenorayGENORAY CO., LTD.OXO2025-12-01
08809244060700GenorayGENORAY CO., LTD.JAA2025-12-01
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08800018422601EXTRON 3DRTECH CorporationOWB2025-06-17
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