DigiX FDX
FDA 510(k) K192541 · Allengers Medical Systems Limited
510(k) numberK192541
Submission
- Device name
- DigiX FDX
- Applicant
- Allengers Medical Systems Limited
Derabassi, Distt Mohali, IN - Received
- September 16, 2019
- Decision date
- October 16, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K253296 | Digital C-ARM with 3DOXO · Traditional | 06/05/2026SE |
| K243734 | Wireless/ Wired X-Ray Flat Panel DetectorsMQB · Special | 04/18/2025SE |
| K223009 | Wireless/Wired X-Ray Flat Panel DetectorsMQB · Traditional | 11/27/2022SE |
| K223060 | DigiX FDXKPR · Special | 10/26/2022SE |
| K220311 | Cardiovascular Angiography SystemOWB · Traditional | 05/03/2022SE |
| K200218 | Digiscan FDXOWB · Traditional | 07/13/2020SE |
| K162529 | DigiX FDXKPR · Traditional | 03/03/2017SE |
Questions and answers
When was DigiX FDX cleared by the FDA?
DigiX FDX (K192541) received a 510(k) decision of Substantially Equivalent on October 16, 2019, 30 days after the submission was received.
What is the product code of K192541?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.