510(k) K201124
K201124 is an FDA 510(k) premarket notification submitted by DRGEM Corporation for the device "TOPAZ Mobile DR System". The FDA issued a decision of Substantially Equivalent on May 19, 2020. 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
- May 19, 2020
- Date Received
- April 27, 2020
- Clearance Type
- Special
- 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