DEVICE: Radiography 7000 M (00884838115521)
Device Identifier (DI) Information
Radiography 7000 M
712010
In Commercial Distribution
Philips Medical Systems DMC GmbH
712010
In Commercial Distribution
Philips Medical Systems DMC GmbH
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 accessories
3. Eleva WorkSpot
In 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)
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
37647 | Mobile basic diagnostic x-ray system, digital |
An 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IZL | System, X-Ray, Mobile |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
06a112bc-89cc-49cb-9c7e-3d7d5a15d663
March 01, 2024
1
February 22, 2024
March 01, 2024
1
February 22, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined