EOSedge
FDA 510(k) K233920 · Eos Imaging
510(k) numberK233920
Submission
- Device name
- EOSedge
- Applicant
- Eos Imaging
Paris, FR - Received
- December 13, 2023
- Decision date
- August 6, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KPR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Dk Medical Systems Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251078 | AutoDensityQIH · Traditional | 11/14/2025SE |
| K251747 | VEA Align; spineEOSQIH · Traditional | 08/15/2025SE |
| K240582 | VEA Align; spineEOSQIH · Traditional | 06/25/2024SE |
| K231917 | VEA AlignQIH · Traditional | 01/05/2024SE |
| K232086 | spineEOSLLZ · Traditional | 10/24/2023SE |
| K202394 | EOSedgeKPR · Special | 09/16/2020SE |
| K192079 | EOSedgeKPR · Traditional | 11/27/2019SE |
| K172346 | sterEOS WorkstationLLZ · Traditional | 06/19/2018SE |
| K160914 | sterEOS WorkstationLLZ · Special | 04/22/2016SE |
| K152788 | EOS SystemKPR · Special | 10/21/2015SE |
Questions and answers
When was EOSedge cleared by the FDA?
EOSedge (K233920) received a 510(k) decision of Substantially Equivalent on August 6, 2024, 237 days after the submission was received.
What is the product code of K233920?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.