510(k) K180663
K180663 is an FDA 510(k) premarket notification submitted by Livermoretech, Inc. for the device "LaVid FMTS DIAGNOSTIC X-RAY SYSTEM". The FDA issued a decision of Substantially Equivalent on May 18, 2018. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Livermoretech, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 2018
- Date Received
- March 14, 2018
- 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