510(k) K242015
K242015 is an FDA 510(k) premarket notification submitted by DRGEM Corporation for the device "TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)". The FDA issued a decision of Substantially Equivalent on December 16, 2024. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. DRGEM Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2024
- Date Received
- July 10, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type