RAYMO Mobile X-ray System (Model: RAYMO)
FDA 510(k) K260085 · DRGEM Corporation
510(k) numberK260085
Submission
- Device name
- RAYMO Mobile X-ray System (Model: RAYMO)
- Applicant
- DRGEM Corporation
Gwangmyeong-Si, KR - Received
- January 12, 2026
- Decision date
- May 14, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 RAYMO Mobile X-ray System (Model: RAYMO) cleared by the FDA?
RAYMO Mobile X-ray System (Model: RAYMO) (K260085) received a 510(k) decision of Substantially Equivalent on May 14, 2026, 122 days after the submission was received.
What is the product code of K260085?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.