510(k) K190601
K190601 is an FDA 510(k) premarket notification submitted by Medicatech USA for the device "MasteRad MX30". The FDA issued a decision of Substantially Equivalent on April 25, 2019. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Medicatech USA has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2019
- Date Received
- March 8, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type