FDA.reportPublic FDA data

X-CEL X-RAY CORPORATION

Primary DI
B216DRH700AC1
Brand
X-CEL X-RAY CORPORATION
Company
ARQUILLA, INC.
Model
DRH-700 A/C
Device description
TABLE TOP X-RAY MACHINE, 15mA, 50-70kV
Published
2022-12-20
Public version status
New
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
K811230000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K811230000X-CELL X-RAY #'S P-75W/P-75MX-Cel X-Ray Corp.1981-06-23KPR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B216DRH700AC1PrimaryHIBCC0

GMDN Terms#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
8154552470guido@xcelxray.com

Regulatory Flags#

DUNS number
062469945
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B216P700MAC1X-CEL X-RAY CORPORATIONP700M A/C2022-08-05
B216715BBD1X-CEL X-RAY CORPORATION715B-BD2016-08-15
B216715RSD1X-CEL X-RAY CORPORATION715R-SD2017-07-19
B216715SD1X-CEL X-RAY CORPORATION715-SD2017-11-22
B216715TBD1X-CEL X-RAY CORPORATION715T-BD2016-08-15
B216BDXC7001X-CEL X-RAY CORPORATIONBDXC-7002017-11-29
B216FB715NT1X-CEL X-RAY CORPORATIONFB-715NT2016-08-15
B216FB910A40K1X-CEL X-RAY CORPORATIONFB910A-40K2017-01-06
B216HDR715A401X-CEL X-RAY CORPORATIONHDR-715A-402016-08-15
B216HDRI715A401X-CEL X-RAY CORPORATIONHDRI-715A-402016-08-15
B216HF718BD1X-CEL X-RAY CORPORATIONHF 718BD2017-07-27
B216LB715NT1X-CEL X-RAY CORPORATIONLB-715NT2016-08-15
B216MB715NT1X-CEL X-RAY CORPORATIONMB-715NT2016-08-15

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
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