DEVICE: DigitalDiagnost C90 (00884838090705)
Device Identifier (DI) Information
DigitalDiagnost C90
712035
In Commercial Distribution
Philips Medical Systems DMC GmbH
712035
In Commercial Distribution
Philips Medical Systems DMC GmbH
The DigitalDiagnost C90 is a high-end digital radiography system, that inlcudes
- Adjustable Straps for Patient Support;
- Battery for SkyPlate E;
- Compression Belt (singles. pull);
- Hand grips (Pair of);
- Infusion bottle holder;
- Lateral cassette holder;
- Mobile Detector Holder;
- Paper roll holder;
- Parking frame for accessories;
- Patient Support for Stitching;
- Remote control holder;
- Side Bar;
- Stretch Grip for VS/VM Stand;
- Table top support
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| Yes | |
| No | |
| Yes | |
| No | |
| No | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 37645 | Stationary basic diagnostic x-ray system, digital |
An 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.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| MQB | Solid state x-ray imager (flat panel/digital imager) |
| KPR | System, X-Ray, Stationary |
| LLZ | System, Image Processing, Radiological |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
9326ff44-8ce8-4d89-91ac-b28f5cc20522
January 10, 2023
5
March 28, 2019
January 10, 2023
5
March 28, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
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