510(k) K954198
K954198 is an FDA 510(k) premarket notification submitted by Voxel for the device "VOXCAM". The FDA issued a decision of Substantially Equivalent on September 29, 1995. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Voxel has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 1995
- Date Received
- September 6, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Multi Format, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2040
- Review Panel
- RA
- Submission Type