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Radiography 7300 C

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 712037

by Philips Medical Systems DMC GmbH

Identity

Trade Name
Radiography 7300 C EUDAMEDFDA UDI
Generic Name
Stationary basic diagnostic x-ray system, digital FDA UDI
Device Name
Fixed Rad-System EUDAMED
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
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 EUDAMED
Class 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

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Similar devices

Also classified as Electromagnetic surgical navigation device tracking system.

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

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