Precision CRF

Primary DI
00884838110588
Brand
Precision CRF
Company
Philips Medical Systems DMC GmbH
Model
706400
Device description
The Precision CRF is a multi-functional general Radiography/ Fluoroscopy (R/F) system and includes• Footrest• Hand GripsRadiation Protection Accessories• Flexible Radiation Protection Apron• Front Radiation Protection ApronAdditional Accessories (Optional)• Monitor Trolley• Monitor Ceiling Suspension• Parking Frame for Accessories• Shoulder Support• Side bar• Compression Belt• Adjustable Lateral Cassette Holder• Leg Supports• Infusion Bottle Holder• Arm Support for Catheterization• Ankle Clamps• Overhead Hand Grip• Adult Headrest• Mattress• Rotatable Stool for Footrest• Pediatric Micturition Set• Stretch Grip for Wall Stand• Bar Code Scanner• Patient Support• Stitching RulerAccessories for the SkyPlate Detector (Optional)• Mobile Detector Holder• Detector Holder Patient Bed• Portable Panel Protector• Detector Handle• WPD Bags• Grids for SkyPlate Detector large
Published
2023-02-14
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
JAASystem, X-Ray, Fluoroscopic, Image-Intensified
KPRSystem, X-Ray, Stationary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
KPRSystem, X-Ray, StationaryRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212837000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212837000ProxiDiagnost N90Philips Medical Systems Dmc GmbH2021-09-21JAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838110588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838110588008848381105888848381105880884838110588

GMDN Terms#

Term, Definition table
TermDefinition
Stationary general-purpose fluoroscopic x-ray system, digitalA stationary general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be viewed in both real-time and delayed format.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314101218
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838115521Radiography 7000 M7120102024-02-22
00884838116016Radiography 7300 C7120372024-06-27
00884838103221ProxiDiagnost N907061102022-01-17
00884838101456CombiDiagnost R907090312021-02-04
00884838090699DigitalDiagnost C907120342019-03-28
00884838090705DigitalDiagnost C907120352019-03-28
00884838065321DigitalDiagnost7120317120312016-09-19
00884838074514DigitalDiagnost7120327120322016-09-19
00884838074521DigitalDiagnost7120337120332016-09-19
00884838102842Telemetry Monitor 5500 1.4 GHz RadioTelemetry Monitor 5500 1.4 GHz Radio8672322026-04-27
00884838076747CombiDiagnost R907090307090302018-05-09
00884838127517CT XS Tube CPO9806-058-000919806-058-000912025-07-31
00884838125322Grid Landscape for SkyPlate E 9896-010-725122025-06-19
00884838125339Grid Landscape for SkyPlate large 9896-010-686242025-06-19
00884838125346Grid Portrait for SkyPlate E 9896-010-725022025-06-19
00884838125353Grid Portrait for SkyPlate large9896-010-686332025-06-19
00884838125360Grid Portrait for SkyPlate small 9896-010-686442025-06-19
00884838125384Grid Portrait Fiber PaxScan4336W9896-010-708322025-06-19
00884838125391Grid Landscape Fiber PaxScan4336W9896-010-708222025-06-19
00884838125421X-Ray Grid 40/12/1409896-010-648922025-06-19

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
08809244060533GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060557GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060632GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060618GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060625GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060700GenorayGENORAY CO., LTD.JAA2025-12-01
08800018422601EXTRON 3DRTECH CorporationJAA2025-06-17
08809244060090GenorayGENORAY CO., LTD.JAA2025-05-02
08800018420805EXTRON 5DRTECH CorporationJAA2023-08-24
08800018420904EXTRON 7DRTECH CorporationJAA2023-08-24
B216DRH700AC1X-CEL X-RAY CORPORATIONARQUILLA, INC.KPR2022-12-20
08809244060120GenorayGENORAY CO., LTD.JAA2022-03-22
088000186009000909FCBRayence Co., Ltd.JAA2021-10-29
B225100000150TAU Model 1000-0015 Mini C-ArmZiehm-Orthoscan, Inc.JAA2021-05-27
08436046003026SEDECALSEDECALKPR2021-02-15
08436046003033SEDECALSEDECALKPR2021-02-15
EZIEZIEHM80001Ziehm 8000Ziehm Imaging GmbHJAA2020-03-12
EZIEZIEHMVISIONFD1651Ziehm Vision FDZiehm Imaging GmbHJAA2020-03-12
08800011121235FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121242FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121259FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121266FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121273FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121280FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121297FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121303FDR ClinicaDRGEM CorporationKPR2019-11-20