FDA.reportPublic FDA data

DRGEM

Primary DI
08800011140441
Brand
DRGEM
Company
DRGEM Corporation
Model
SGXR-32SD
Device description
*Line power rating: 400V3~*Max Tube voltage: 125kV
Published
2019-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KPRSystem, X-Ray, Stationary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPRSystem, X-Ray, StationaryRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102408000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102408000DIGITAL DIAGNOSTIC X-RAY SYSTEMDRGEM Corporation2010-12-27KPR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800011140441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800011140441088000111404418800011140441

GMDN Terms#

Term, Definition table
TermDefinition
Stationary basic diagnostic x-ray system, digitalAn assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

Regulatory Flags#

DUNS number
688477319
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800011150129DRGEMRAYMO2026-05-20
08800011150136DRGEMRAYMO2026-05-20
08800011140076DRGEMGXR-52SD2019-10-07
08800011140090DRGEMGXR-82SD2019-10-07
08800011140106DRGEMGXR-C32SD2019-10-07
08800011140113DRGEMGXR-C40SD2019-10-07
08800011140120DRGEMGXR-C52SD2019-10-07
08800011140137DRGEMGXR-U32SD2019-10-07
08800011140144DRGEMGXR-U40SD2019-10-07
08800011140182DRGEMGXR-32SD2019-10-07
08800011140199DRGEMGXR-32SD2019-10-07
08800011140205DRGEMGXR-32SD2019-10-07
08800011140212DRGEMGXR-32SD2019-10-07
08800011140229DRGEMGXR-40SD2019-10-07
08800011140236DRGEMGXR-40SD2019-10-07
08800011140243DRGEMGXR-40SD2019-10-07
08800011140250DRGEMGXR-40SD2019-10-07
08800011140267DRGEMGXR-52SD2019-10-07
08800011140274DRGEMGXR-68SD2019-10-07
08800011140281DRGEMGXR-82SD2019-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08908021109004PRORAD 3NCPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDKPR2026-05-07
08908021109011PRORAD 2FCPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDKPR2026-05-07
08809365280001SG HealthcareSG Healthcare Co., Ltd.KPR2026-04-24
08809365281015SG HealthcareSG Healthcare Co., Ltd.KPR2026-04-24
00198953056103DefiniumGE Hualun Medical Systems Co., LtdKPR2026-02-12
00198953056158DefiniumGE Hualun Medical Systems Co., LtdKPR2026-02-12
04056869297309MOBILETT ImpactSiemens Healthcare GmbHKPR2025-11-20
00195278913807DefiniumGE Hualun Medical Systems Co., LtdKPR2024-10-30
00195278840226DiscoveryGE Hualun Medical Systems Co., LtdKPR2024-07-04
04540217071319RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
04540217071326RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
04540217071333RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
04540217071340RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
04540217071357RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
04540217071364RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
00195278526892DefiniumGE Hualun Medical Systems Co., LtdKPR2023-09-18
00884838110588Precision CRFPhilips Medical Systems DMC GmbHKPR2023-02-14
B216DRH700AC1X-CEL X-RAY CORPORATIONARQUILLA, INC.KPR2022-12-20
00884838103221ProxiDiagnost N90Philips Medical Systems DMC GmbHKPR2022-01-17
08436046003026SEDECALSEDECALKPR2021-02-15
08436046003033SEDECALSEDECALKPR2021-02-15
00195278070265DefiniumGE Hualun Medical Systems Co., LtdKPR2020-11-24
00810035220386Radmedix AcuityFDRRADMEDIX, LLCKPR2020-09-18
00810035220393Radmedix AcuityFDR+RADMEDIX, LLCKPR2020-09-18
00810035220409Radmedix AcuityCDRRADMEDIX, LLCKPR2020-09-18
00810035220416Radmedix AcuitySDRRADMEDIX, LLCKPR2020-09-18
00810035220423Radmedix AcuitySDR+RADMEDIX, LLCKPR2020-09-18
00810030350071uDRUIH TECHNOLOGIES LLCKPR2020-05-26
00810030350002uDRUIH TECHNOLOGIES LLCKPR2020-04-29
08800011121235FDR ClinicaDRGEM CorporationKPR2019-11-20