KPR · System, X-Ray, Stationary
Radiology · 21 CFR 892.1680 · Class 2
Overview
| Product Code | KPR |
|---|---|
| Device Name | System, X-Ray, Stationary |
| Regulation | 21 CFR 892.1680 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Special Controls
*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Recent Cleared Devices (20 of 355)
Showing 20 most recent of 355 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253446 | AeroDR TX c02 | Dk Medical Systems Co., Ltd. | Apr 10, 2026 | SESE |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector | Carestream Health | Jan 20, 2026 | SESE |
| K252000 | uDR Arria & uDR Aris | Shanghai United Imaging Healthcare Co., Ltd. | Nov 26, 2025 | SESE |
| K251167 | uDR Aurora CX | Shanghai United Imaging Healthcare Co., Ltd. | Sep 19, 2025 | SESE |
| K250788 | Definium Tempo Select | Ge Hualun Medical Systems Co. , Ltd. | Aug 28, 2025 | SESE |
| K250790 | INNOVISION-DXII | Dk Medical Systems Co., Ltd. | Aug 1, 2025 | SESE |
| K250738 | YSIO X.pree | Siemens Medical Solutions | Jul 31, 2025 | SESE |
| K242019 | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | Jan 7, 2025 | SESE |
| K242499 | Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) | Shenzhen Sontu Medical Imaging Equipment Co., Ltd. | Jan 6, 2025 | SESE |
| K242119 | INNOVISION-EXII | Dk Medical System | Jan 3, 2025 | SESE |
| K241068 | uDR 780i | Shanghai United Imaging Healthcare Co., Ltd. | Nov 1, 2024 | SESE |
| 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 | Oct 23, 2024 | SESE |
| K242678 | Definium Pace Select ET | Ge Hualun Medical Systems Co. , Ltd. | Oct 1, 2024 | SESE |
| K242478 | GF85 (models GF85-3P, GF85-SP) | Samsung Electronics Co., Ltd. | Sep 19, 2024 | SESE |
| K233920 | EOSedge | Eos Imaging | Aug 6, 2024 | SESE |
| K233530 | 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) | DRTECH Corporation | Jul 26, 2024 | SESE |
| K233662 | Radiography 7300 C | Philips Medical Systems Dmc GmbH | Jun 13, 2024 | SESE |
| K233543 | YSIO X.pree | Siemens Medical Solutions | May 21, 2024 | SESE |
| K233719 | FDR Visionary Suite | Shimadzu Corporation | Mar 28, 2024 | SESE |
| K233381 | DRX-Evolution Plus System | Carestream Health, Inc. | Mar 12, 2024 | SESE |
Top Applicants
- Samsung Electronics Co., Ltd. — 20 clearances
- Siemens Medical Solutions USA, Inc. — 13 clearances
- Imaging Dynamics Company , Ltd. — 11 clearances
- Carestream Health, Inc. — 10 clearances
- Philips Medical Systems (Cleveland), Inc. — 8 clearances
