FDA.reportPublic FDA data

NA

Primary DI
00840682141307
Brand
NA
Company
GE MEDICAL SYSTEMS
Model
IGS WF SP
Catalog number
5796561
Device description
IGS WF SP UDI - CE
Published
2018-11-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00840682141307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682141307008406821413078406821413070840682141307

GMDN Terms#

Term, Definition table
TermDefinition
Foot-switch, electricalAn electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
266062561
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198953076873SenoIris12025-11-24
00840682102384AW Server3.22016-08-01
00195278661999Senographe PristinaNAY22023-07-28
00195278485144AlliaIGS 558728922022-04-13
00195278347596Pristina SerenaKAS22021-04-26
00195278022745Senographe PristinaEKB42021-05-21
00195278925428Pristina PaddleSLD LS2025-01-09
00195278527899Pristina PaddleSLD 2D PF2022-05-02
00195278527950Pristina Paddle19X23SLD2022-03-09
00195278527882Pristina Paddle24x29 STD2022-03-08
00195278527912Pristina Paddle24x29 FLEX2022-03-08
00195278527929Pristina PaddleSLD IMP2022-03-08
00195278527936Pristina PaddleSLD RND2022-03-08
00195278527943Pristina PaddleSLD 2D2022-03-08
00195278527905Pristina PaddleSLD SQR2022-03-07
00195278330390Pristina PaddleSLD FX2021-01-14
00198953109281Senographe PristinaPOZ22025-12-01
00198953052488AlliaMoveo59818762025-12-17
10198953054311not applicablePRISTINA 2.102025-11-28
00840682122603not applicable57276692017-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190376652313CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652320CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652337CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376668307CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
BN981BN002020Bolt NavigationCircinus Medical Technology LLCOWB2026-09-25
BN981BN00202BX101Bolt NavigationCircinus Medical Technology LLCOWB2026-09-25
00680211003306PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2026-09-22
00680211003290PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2026-09-21
00850079606081MC2 Portable X-ray SystemOXOS Medical, Inc.OXO2026-09-21
00850079606081MC2 Portable X-ray SystemOXOS Medical, Inc.OWB2026-09-21
00850079606098EmitterOXOS Medical, Inc.OXO2026-09-21
00850079606098EmitterOXOS Medical, Inc.OWB2026-09-21
00850079606104CassetteOXOS Medical, Inc.OXO2026-09-21
00850079606104CassetteOXOS Medical, Inc.OWB2026-09-21
04547410582901FDR CROSS SlimFUJIFILM CORPORATIONJAA2026-08-14
04547410582901FDR CROSS SlimFUJIFILM CORPORATIONOWB2026-08-14
00854810007199iXRSIcRco, Inc.JAA2026-07-22
00860014944611nView s1 with nav optionNVIEW MEDICAL INC.OWB2026-07-08
00860014944611nView s1 with nav optionNVIEW MEDICAL INC.JAA2026-07-08
00860014944611nView s1 with nav optionNVIEW MEDICAL INC.OXO2026-07-08
00680211003276PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2026-07-06
00848340021879Mitaka DrapeADVANCE MEDICAL DESIGNS, INC.JAA2026-06-25
05060508110057Cydar MapsCYDAR LIMITEDOWB2026-05-27
08055186671225A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
08055186671225A.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 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 SRLOWB2026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21