RAYMO Mobile X-ray System (Model: RAYMO)— 510(k) K260085
Substantially EquivalentDRGEM Corporation
FDA 510(k) clearance K260085 for RAYMO Mobile X-ray System (Model: RAYMO), Substantially Equivalent on 2026-05-14. Applicant: DRGEM Corporation. Device class: 2.
Summary
DRGEM's RAYMO Mobile X-ray System (Model: RAYMO) is filed under IZL, mobile x-ray systems.
Class II, 21 CFR 892.1720. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
DRGEM filed from Gwangmyeong-Si, South Korea. The decision came 122 calendar days after receipt (January 12 to May 14, 2026).
Clearance details
- Applicant
- DRGEM Corporation
- Product code
- Product code IZL
- Device class
- Class 2
- Regulation
- 21 CFR 892.1720
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gwangmyeong-Si, KR
Recent devices under product code IZL
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view allAdverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.