TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)— 510(k) K242015
Substantially EquivalentDRGEM Corporation
FDA 510(k) clearance K242015 for TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D), Substantially Equivalent on 2024-12-16. Applicant: DRGEM Corporation.
Clearance details
- Applicant
- DRGEM Corporation
- Product code
- Code IZL
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gwangmyeong-Si, KR
Adverse 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.