Philips Radiology Smart Assistant
FDA 510(k) K212186 · Philips Medical Systems Dmc GmbH
510(k) numberK212186
Submission
- Device name
- Philips Radiology Smart Assistant
- Applicant
- Philips Medical Systems Dmc GmbH
Hamburg, DE - Received
- July 13, 2021
- Decision date
- December 13, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…KPR · Traditional | DRTECH Corporation | 09/08/2026SE |
| K260488 | MULTIX Impact; MULTIX Impact CKPR · Traditional | Siemens Medical Solutions USA, Inc. | 08/31/2026SE |
| K260481 | GC85AKPR · Traditional | Samsung Electronics Co., Ltd. | 08/27/2026SE |
| K260482 | DRE DuoKPR · Traditional | Jpi Healthcare Co, Ltd. | 06/15/2026SE |
| K253446 | AeroDR TX c02KPR · Traditional | Dk Medical Systems Co., Ltd. | 04/10/2026SE |
| 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 |
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| 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 |
| 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 Philips Radiology Smart Assistant cleared by the FDA?
Philips Radiology Smart Assistant (K212186) received a 510(k) decision of Substantially Equivalent on December 13, 2021, 153 days after the submission was received.
What is the product code of K212186?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.