FDA.reportPublic FDA data

PXS-710D

Primary DI
00868162000296
Brand
PXS-710D
Company
SOURCE-RAY, INC.
Model
PXS-710D
Catalog number
900100
Device description
X-Ray System, General Purpose Podiatry
Published
2017-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K133959000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133959000PODIATRY X-RAY SYSTEMSource-Ray, Inc.2015-01-22KPR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868162000296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868162000296008681620002968681620002960868162000296

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
631-244-8200Ato@sourceray.com

Regulatory Flags#

DUNS number
113928654
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00868162000289RC-115RC-1159000352016-09-09
00868162000210XRS-125-7K-PXRS-125-7K-P9000432016-09-09
00867538000311XRS-140-15K-PXRS-140-15K-P9000512022-02-18
00867538000328XRS-140-7.5K-PXRS-140-7.5K-P9001452022-02-16
00867538000304UC-5000UC-50009001172017-01-30
00868162000234SR-115-CGSR-1159000332016-09-09
00868162000241SR-130-GSR-130-G9100562016-09-09
00868162000258SR-130-CSR-130-C9100022016-09-09
00868162000265SR-1260-CSR-1260-C9102242016-09-09
00868162000272SR-1260-GSR-1260-G9102222016-09-09
00868162000203SB-60-333SB-60-3339000462016-09-09
00868162000227SB-80-200RSB-80-200R9000862016-09-09

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
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
08800011121242FDR ClinicaDRGEM CorporationKPR2019-11-20