510(k) K142773
- Device
- EOS System
- Applicant
- EOS IMAGING
- 510(k) number
- K142773
- Product code
- KPR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-01-22
- Date received
- 2014-09-25
- Regulation
- 892.1680
- Classification name
- System, X-ray, Stationary
- Medical specialty
- Radiology
- Review panel
- Radiology
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code KPR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253446 | AeroDR TX c02 | Dk Medical Systems Co., Ltd. | 2026-04-10 |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector | Carestream Health | 2026-01-20 |
| K252000 | uDR Arria & uDR Aris | Shanghai United Imaging Healthcare Co., Ltd. | 2025-11-26 |
| K251167 | uDR Aurora CX | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-19 |
| K250788 | Definium Tempo Select | Ge Hualun Medical Systems Co. , Ltd. | 2025-08-28 |
| K250790 | INNOVISION-DXII | Dk Medical Systems Co., Ltd. | 2025-08-01 |
| K250738 | YSIO X.pree | Siemens Medical Solutions | 2025-07-31 |
| K242019 | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | 2025-01-07 |
| K242499 | Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) | Shenzhen Sontu Medical Imaging Equipment Co., Ltd. | 2025-01-06 |
| K242119 | INNOVISION-EXII | Dk Medical System | 2025-01-03 |
| K241068 | uDR 780i | Shanghai United Imaging Healthcare Co., Ltd. | 2024-11-01 |
| K242847 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA); | DRTECH Corporation | 2024-10-23 |
| K242678 | Definium Pace Select ET | Ge Hualun Medical Systems Co. , Ltd. | 2024-10-01 |
| K242478 | GF85 (models GF85-3P, GF85-SP) | Samsung Electronics Co., Ltd. | 2024-09-19 |
| K233920 | EOSedge | Eos Imaging | 2024-08-06 |
Legacy Summary#
summary
FDA Review#
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