DRE Duo
FDA 510(k) K260482 · Jpi Healthcare Co, Ltd.
510(k) numberK260482
Submission
- Device name
- DRE Duo
- Applicant
- Jpi Healthcare Co, Ltd.
Seoul, KR - Received
- February 13, 2026
- Decision date
- June 15, 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 |
| 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 |
| K250738 | YSIO X.preeKPR · Traditional | Siemens Medical Solutions | 07/31/2025SE |
More from Siemens Medical Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K244010 | ExamVue ApexMQB · Traditional | 02/24/2025SE |
| K213057 | ExamVue DuoKPR · Traditional | 02/18/2022SE |
| K160143 | ClearVision ExamVue Flat Panel DetectorMQB · Traditional | 10/28/2016SE |
| K142930 | Exam Vue DRKPR · Traditional | 04/17/2015SE |
| K102327 | Clearvision DR 7000FMQB · Traditional | 04/13/2012SE |
| K101779 | Clearvision DR 2000 Digital Radiography X-Ray SystemKPR · Traditional | 05/16/2011SE |
| K955706 | Jpi Automatic X-Ray Film ProcessorIXW · Traditional | 02/12/1996SE |
| K954161 | Jpi Intensifying ScreenEAM · Traditional | 02/02/1996SE |
| K950043 | Jpi Automatic X-Ray Film ProcessorIXW · Traditional | 05/10/1995SE |
Questions and answers
When was DRE Duo cleared by the FDA?
DRE Duo (K260482) received a 510(k) decision of Substantially Equivalent on June 15, 2026, 122 days after the submission was received.
What is the product code of K260482?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.