Identity
- Trade Name
- Radiography 7300 C EUDAMEDFDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- Fixed Rad-System EUDAMEDRadiography 7300 C is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The proposed Radiography 7300 C is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE. Together with the tube these components form the radiography Image Chain. The additional option of the portable wireless detector i.e. the SkyPlate family can be used for free exposures as well as in the patient support table or in the vertical stand. The proposed Radiography 7300 C uses the following Accessories, • Parking frame for accessories • Handgrips • Side Bar • Adjustable straps • Compression Belt • Infusion Bottle holder TH-S • Infusion Bottle holder TH2 • Support for CPR (Cardio Pulmonary Resuscitation) • Stretch Grip • Remote control holder • Charger 2EZ • Grid’s for Skyplayte Wireless Portable Detectors • Grid’s for Fixed Detectors • Detector Handle • Detector holder for patient bed • Mobile detector holder • Portable panel protector • WPD Hygienic bags • Patient support • Adjustable Straps for Patient Support • Stitching Ruler Radiography 7300C is a successor of DigitalDiagnost C90 (Release Version 1.1). The main differences of Radiography 7300 C versus DigitalDiagnost C90 are optional new features: • Assisted collimation & Assisted detector height alignment (Smart Collimation Thorax / SCT) • Overlays including On-screen collimation & AEC Visualization FDA UDI
- Model / Reference
- 712037 EUDAMEDFDA UDI
- Description
- Radiography 7300 C is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The proposed Radiography 7300 C is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE. Together with the tube these components form the radiography Image Chain. The additional option of the portable wireless detector i.e. the SkyPlate family can be used for free exposures as well as in the patient support table or in the vertical stand. The proposed Radiography 7300 C uses the following Accessories, • Parking frame for accessories • Handgrips • Side Bar • Adjustable straps • Compression Belt • Infusion Bottle holder TH-S • Infusion Bottle holder TH2 • Support for CPR (Cardio Pulmonary Resuscitation) • Stretch Grip • Remote control holder • Charger 2EZ • Grid’s for Skyplayte Wireless Portable Detectors • Grid’s for Fixed Detectors • Detector Handle • Detector holder for patient bed • Mobile detector holder • Portable panel protector • WPD Hygienic bags • Patient support • Adjustable Straps for Patient Support • Stitching Ruler Radiography 7300C is a successor of DigitalDiagnost C90 (Release Version 1.1). The main differences of Radiography 7300 C versus DigitalDiagnost C90 are optional new features: • Assisted collimation & Assisted detector height alignment (Smart Collimation Thorax / SCT) • Overlays including On-screen collimation & AEC Visualization FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838116016 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM440SS EUDAMED
- FDA Product Code
- KPR FDA UDI
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Stationary basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Electromagnetic surgical navigation device tracking system
Radiography 7300 C by Philips Medical Systems DMC GmbH — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233662 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0884838BM440SS | Class IIb | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems DMC GmbH
- EUDAMED SRN
- DE-MF-000005362
Sources (3)
- EUDAMED 30842274-e233-433e-9a42-355b62e6d80d 61 fields · synced Jul 27, 2026
- FDA UDI 5939112b-4315-4844-81d0-571a333f7740 33 fields · synced May 30, 2026
- FDA 510(k) K233662 1 fields · synced May 18, 2026