Radiography 7300 C

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…

Registry build 21.09.26

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

7manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
6recalls on this code

Who Else Makes It

Concentrated in Shanghai (3), Beijing (2), Jiangsu (1).

Chinese manufacturers registered for FDA product code KPR
Manufacturer City Province Registered as Device types
GE Hangwei Medical Systems Co., Ltd. Beijing Beijing Specification developer 22
GE Healthcare (China) Co., Ltd. Beijing Beijing Specification developer 22
Shanghai United Imaging Healthcare Co., Ltd. Shanghai Shanghai Manufacturer 12
Siemens Shanghai, Medical Equipment Ltd. Shanghai Shanghai Contract manufacturer 10
Carestream Health, Inc., Global R&D Center Shanghai Shanghai Specification developer 8
Philips Healthcare (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 5
Orich Medical Equipment (Tianjin) Co., Ltd. Tianjin Tianjin Manufacturer 5

Record

Regulatory record for Radiography 7300 C
Listed by Philips Medical Systems DMC GmbH, Germany
FDA product code KPR
Device type System, X-Ray, Stationary
Device class Class 2
Regulation 21 CFR 892.1680
Establishment Specification developer, Complaint-file establishment, Manufacturer, Exporter
Record published 2024-06-27
Record revised 2026-05-22 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries serial number
Storage Storage environment temperature -25 to 70 °C; Storage environment humidity 5 to 95 % RH; Storage environment atmospheric pressure 70 to 110 KiloPascal

Catalogue Numbers

Catalogue numbers for Radiography 7300 C
Catalogue number Size Status
712037 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Drgem Drgem Corporation 171
Q-RAD System Carestream Health, Inc. 159
DRX – Ascend System Carestream Health, Inc. 121
FDR Clinica Drgem Corporation 41
RADspeed Pro Shimadzu Corp. 31
FDR Visionary Suite Shimadzu Corp. 17
Exsys DEXi Drtech Corporation 15
Del Medical, Inc. DEL Medical, Inc. 15
GXR-Es,ecs Diagnostic X-ray System Drgem Corporation 14
X-CEL X-RAY Corporation Arquilla, Inc. 14
DRX-Evolution Plus System Carestream Health, Inc. 12
Carestream DRX-Evolution Carestream Health, Inc. 10

Showing 12 of 138. All products under System, X-Ray, Stationary

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K233662 2024-06-13
K212186 2021-12-13
K210692 2021-04-02

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Radiography 7300 C
Recalled by Identified by Initiated FDA class Root cause Reason Quantity
Philips Medical Systems DMC GmbH UDI-DI 2025-10-01 Class II Device Design Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024
through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required
for manual movement) due to potenti
284 units

Recalls

5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity
2025-10-01 Class II Device Design Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024
through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required
for manual movement) due to potenti
12 units
2021-05-19 Class II Radiation Control for Health and Safety Act Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallst 140 systems in total, (Updated 1/30/2023).
2021-05-19 Class II Radiation Control for Health and Safety Act Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallst 140 systems in total, (Updated 1/30/2023).
2021-05-19 Class II Radiation Control for Health and Safety Act Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallst 140 systems in total, (Updated 1/30/2023).
2021-05-19 Class II Radiation Control for Health and Safety Act Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallst 140 systems in total, (Updated 1/30/2023).

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer