DIAMOND-5A/6A/8A
FDA 510(k) K202156 · DRGEM Corporation
510(k) numberK202156
Submission
- Device name
- DIAMOND-5A/6A/8A
- Applicant
- DRGEM Corporation
Gwangmyeong-Si, KR - Received
- July 27, 2020
- Decision date
- September 10, 2020
- 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 |
|---|---|---|
| K260085 | RAYMO Mobile X-ray System (Model: RAYMO)IZL · Traditional | 05/14/2026SE |
| K251443 | PromoIZL · Traditional | 08/22/2025SE |
| K242019 | GXR-Series Diagnostic X-Ray SystemKPR · Traditional | 01/07/2025SE |
| 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 |
| 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 DIAMOND-5A/6A/8A cleared by the FDA?
DIAMOND-5A/6A/8A (K202156) received a 510(k) decision of Substantially Equivalent on September 10, 2020, 45 days after the submission was received.
What is the product code of K202156?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.