Radiography 7300 C
FDA 510(k) K233662 · Philips Medical Systems Dmc GmbH
510(k) numberK233662
Submission
- Device name
- Radiography 7300 C
- Applicant
- Philips Medical Systems Dmc GmbH
Hamburg, DE - Received
- November 15, 2023
- Decision date
- June 13, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…KPR · Traditional | Carestream Health | 01/20/2026SE |
| K252000 | uDR Arria & uDR ArisKPR · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 11/26/2025SE |
| K251167 | uDR Aurora CXKPR · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 09/19/2025SE |
| K250788 | Definium Tempo SelectKPR · Traditional | Ge Hualun Medical Systems Co. , Ltd. | 08/28/2025SE |
| K250790 | Innovision-DxiiKPR · Traditional | Dk Medical Systems Co., Ltd. | 08/01/2025SE |
More from Dk Medical Systems Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K233678 | Radiography 7000 MIZL · Traditional | 02/14/2024SE |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400)JAA · Special | 01/11/2024SE |
| K232910 | CombiDiagnost R90JAA · Special | 10/19/2023SE |
| K212186 | Philips Radiology Smart AssistantKPR · Traditional | 12/13/2021SE |
| K212837 | ProxiDiagnost N90JAA · Special | 09/21/2021SE |
| K210692 | DigitalDiagnostKPR · Special | 04/02/2021SE |
| K203087 | CombiDiagnost R90JAA · Traditional | 12/03/2020SE |
| K202564 | DigitalDiagnost C90MQB · Special | 09/30/2020SE |
| K182973 | DigitalDiagnost C90MQB · Traditional | 01/11/2019SE |
| K173433 | ProxiDiagnost N90OWB · Traditional | 02/05/2018SE |
Questions and answers
When was Radiography 7300 C cleared by the FDA?
Radiography 7300 C (K233662) received a 510(k) decision of Substantially Equivalent on June 13, 2024, 211 days after the submission was received.
What is the product code of K233662?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.