Radiography 7000 M

Primary DI
00884838115521
Brand
Radiography 7000 M
Company
Philips Medical Systems DMC GmbH
Model
712010
Device description
Radiography 7000 M digital mobile is a new motorized mobile x-ray system that includes:1. Base Unit ( Sedecal Mobile X-ray system - SM-IV, cleared under K232185 August 21, 2023)2. SkyPlate Family of detectors (Wireless Portable Detectors) and their accessories3. Eleva WorkSpotIn addition, the following accessories can be used together with the system - Raidography 7000 M: - Detector Holder f. Patient Bed- Grid Landsc. SkyPlateE Large- Grid Landscape SkyPlate Large- Grid Portr. SkyPlate E Large- Grid Portrait SkyPlate Large- Grid Portrait SkyPlate Small- Handle for Skyplate Large- Portable Panel Protector- Wireless Detect. Mobile Holder - Set of 50 WPD Hygienic Bags (large)- Set of 50 WPD Hygienic Bags (small)
Published
2024-02-22
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
IZLSystem, X-Ray, Mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZLSystem, X-Ray, MobileRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838115521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838115521008848381155218848381155210884838115521

GMDN Terms#

Term, Definition table
TermDefinition
Mobile basic diagnostic x-ray system, digitalAn assembly of devices that comprise a digital general-purpose mobile 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 and the mobile design allows it to operate on mains or battery power and to be driven or pushed by an operator to various locations within a building or facility. It is commonly used for bedside imaging and for interventional and intraoperative imaging. It consists of basic modular configurations that can be upgraded. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
314101218
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00884838125438X-Ray Grid 40/12/180 9896-010-646722025-06-19

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