Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1680](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1680) → KPR — System, X-Ray, Stationary # KPR · System, X-Ray, Stationary _Radiology · 21 CFR 892.1680 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR ## Overview - **Product Code:** KPR - **Device Name:** System, X-Ray, Stationary - **Regulation:** [21 CFR 892.1680](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1680) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) - **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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K253446.md) | AeroDR TX c02 | Dk Medical Systems Co., Ltd. | Apr 10, 2026 | SESE | | [K250954](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K250954.md) | 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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K252000.md) | uDR Arria & uDR Aris | Shanghai United Imaging Healthcare Co., Ltd. | Nov 26, 2025 | SESE | | [K251167](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K251167.md) | uDR Aurora CX | Shanghai United Imaging Healthcare Co., Ltd. | Sep 19, 2025 | SESE | | [K250788](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K250788.md) | Definium Tempo Select | Ge Hualun Medical Systems Co. , Ltd. | Aug 28, 2025 | SESE | | [K250790](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K250790.md) | INNOVISION-DXII | Dk Medical Systems Co., Ltd. | Aug 1, 2025 | SESE | | [K250738](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K250738.md) | YSIO X.pree | Siemens Medical Solutions | Jul 31, 2025 | SESE | | [K242019](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K242019.md) | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | Jan 7, 2025 | SESE | | [K242499](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K242499.md) | Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) | Shenzhen Sontu Medical Imaging Equipment Co., Ltd. | Jan 6, 2025 | SESE | | [K242119](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K242119.md) | INNOVISION-EXII | Dk Medical System | Jan 3, 2025 | SESE | | [K241068](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K241068.md) | uDR 780i | Shanghai United Imaging Healthcare Co., Ltd. | Nov 1, 2024 | SESE | | [K242847](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K242847.md) | 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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K242678.md) | Definium Pace Select ET | Ge Hualun Medical Systems Co. , Ltd. | Oct 1, 2024 | SESE | | [K242478](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K242478.md) | GF85 (models GF85-3P, GF85-SP) | Samsung Electronics Co., Ltd. | Sep 19, 2024 | SESE | | [K233920](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K233920.md) | EOSedge | Eos Imaging | Aug 6, 2024 | SESE | | [K233530](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K233530.md) | 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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K233662.md) | Radiography 7300 C | Philips Medical Systems Dmc GmbH | Jun 13, 2024 | SESE | | [K233543](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K233543.md) | YSIO X.pree | Siemens Medical Solutions | May 21, 2024 | SESE | | [K233719](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K233719.md) | FDR Visionary Suite | Shimadzu Corporation | Mar 28, 2024 | SESE | | [K233381](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K233381.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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