Radiographic System Challenge X
FDA 510(k) K202293 · Sedecal., Sa.
510(k) numberK202293
Submission
- Device name
- Radiographic System Challenge X
- Applicant
- Sedecal., Sa.
Algete, ES - Received
- August 13, 2020
- Decision date
- October 7, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
| K260482 | DRE DuoKPR · Traditional | Jpi Healthcare Co, Ltd. | 06/15/2026SE |
| 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 |
More from Dk Medical Systems Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K232185 | Sm-IvIZL · Special | 08/21/2023SE |
| K222951 | Sm-VIZL · Abbreviated | 11/21/2022SE |
| K221803 | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.IZL · Special | 07/18/2022SE |
| K212291 | PhoenixIZL · Traditional | 09/14/2021SE |
| K203537 | Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic SystemsKPR · Abbreviated | 02/01/2021SE |
| K192936 | Soltus 500IZL · Special | 11/15/2019SE |
| K192011 | PhoeniXIZL · Abbreviated | 09/25/2019SE |
| K191813 | MobileDiagnost wDR 2.2IZL · Special | 08/02/2019SE |
| K173299 | Dragon X SPSL4HC, Dragon X SPSL8HCIZL · Special | 01/26/2018SE |
| K161345 | RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRIZL · Special | 07/06/2016SE |
Questions and answers
When was Radiographic System Challenge X cleared by the FDA?
Radiographic System Challenge X (K202293) received a 510(k) decision of Substantially Equivalent on October 7, 2020, 55 days after the submission was received.
What is the product code of K202293?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.