K242015
- 510(k) number
- K242015
- Device name
- TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)
- Applicant
- DRGEM Corporation KR
- Product code
- IZL — System, X-Ray, Mobile
- Decision date
- 2024-12-16
- Date received
- 2024-07-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K242015.pdf
Official FDA record: K242015
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.