GXR-Series Diagnostic X-Ray System
FDA 510(k) K242019 · DRGEM Corporation
510(k) numberK242019
Submission
- Device name
- GXR-Series Diagnostic X-Ray System
- Applicant
- DRGEM Corporation
Gwangmyeong-Si, KR - Received
- July 10, 2024
- Decision date
- January 7, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…KPR · Traditional | DRTECH Corporation | 09/08/2026SE |
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| 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 |
More from Dk Medical Systems Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260085 | RAYMO Mobile X-ray System (Model: RAYMO)IZL · Traditional | 05/14/2026SE |
| K251443 | PromoIZL · Traditional | 08/22/2025SE |
| K242015 | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)IZL · Traditional | 12/16/2024SE |
| K232178 | GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)KPR · Traditional | 09/19/2023SE |
| K202572 | GXR-Series Diagnostic X-Ray SystemKPR · Special | 09/24/2020SE |
| K202156 | DIAMOND-5A/6A/8AKPR · Special | 09/10/2020SE |
| K201124 | TOPAZ Mobile DR SystemIZL · Special | 05/19/2020SE |
| K192453 | DIAMOND-5A/6A/8AKPR · Special | 10/01/2019SE |
| K192364 | GXR-Series Diagnostic X-Ray SystemKPR · Traditional | 09/26/2019SE |
| K183292 | Topaz Mobile DR SystemIZL · Traditional | 05/15/2019SE |
Questions and answers
When was GXR-Series Diagnostic X-Ray System cleared by the FDA?
GXR-Series Diagnostic X-Ray System (K242019) received a 510(k) decision of Substantially Equivalent on January 7, 2025, 181 days after the submission was received.
What is the product code of K242019?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.