CombiDiagnost R90
FDA 510(k) K232910 · Philips Medical Systems Dmc GmbH
510(k) numberK232910
Submission
- Device name
- CombiDiagnost R90
- Applicant
- Philips Medical Systems Dmc GmbH
Hamburg, DE - Received
- September 19, 2023
- Decision date
- October 19, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K253103 | Nexus DRF Digital X-ray Imaging SystemJAA · Traditional | Varex Imaging Corporation | 05/29/2026SE |
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| K242488 | Soteria E-ViewJAA · Traditional | Omega Medical Imaging, LLC | 01/06/2025SE |
| K242948 | Adora DRFi (04550010)JAA · Traditional | Nrt X-Ray A/S | 12/23/2024SE |
| K233380 | TRIDENT Mobile Fluoroscopy SystemJAA · Traditional | Dornier Medtech America | 06/26/2024SE |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400)JAA · Special | Philips Medical Systems Dmc GmbH | 01/11/2024SE |
| K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5JAA · Special | Canon Medical Systems Corporation | 09/12/2023SE |
| K220871 | NautilusJAA · Special | Dornier Medtech America, Inc. | 04/18/2022SE |
| K212890 | Nyquist.IQJAA · Traditional | Omega Medical Imaging, LLC | 12/13/2021SE |
| K212837 | ProxiDiagnost N90JAA · Special | Philips Medical Systems Dmc GmbH | 09/21/2021SE |
More from Philips Medical Systems Dmc GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K233662 | Radiography 7300 CKPR · Traditional | 06/13/2024SE |
| K233678 | Radiography 7000 MIZL · Traditional | 02/14/2024SE |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400)JAA · Special | 01/11/2024SE |
| 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 CombiDiagnost R90 cleared by the FDA?
CombiDiagnost R90 (K232910) received a 510(k) decision of Substantially Equivalent on October 19, 2023, 30 days after the submission was received.
What is the product code of K232910?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.