DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
FDA 510(k) K250954 · Carestream Health
510(k) numberK250954
Submission
- Device name
- DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
- Applicant
- Carestream Health
Rochester, NY, US - Received
- March 28, 2025
- Decision date
- January 20, 2026
- 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 |
| 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 |
| K250738 | YSIO X.preeKPR · Traditional | Siemens Medical Solutions | 07/31/2025SE |
More from Siemens Medical Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemIZL · Traditional | 03/11/2026SE |
| K251168 | Image SuiteLLZ · Traditional | 09/04/2025SE |
| K241505 | DRX-Revolution Mobile X-ray SystemIZL · Traditional | 12/10/2024SE |
| K233381 | DRX-Evolution Plus SystemKPR · Traditional | 03/12/2024SE |
| K223842 | DRX - CompassKPR · Special | 01/20/2023SE |
| K213568 | DRX-Rise Mobile X-ray SystemIZL · Traditional | 03/23/2022SE |
| K213307 | Eclipse II with Smart Noise CancellationMQB · Traditional | 01/14/2022SE |
| K202441 | Eclipse II with Smart Noise CancellationMQB · Traditional | 04/02/2021SE |
| K203159 | Lux 35 DetectorMQB · Special | 12/02/2020SE |
| K201373 | DRX-CompassKPR · Special | 06/26/2020SE |
Questions and answers
When was DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector cleared by the FDA?
DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector (K250954) received a 510(k) decision of Substantially Equivalent on January 20, 2026, 298 days after the submission was received.
What is the product code of K250954?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.