510(k) K954199
K954199 is an FDA 510(k) premarket notification submitted by Voxel for the device "VOXBOX". The FDA issued a decision of Substantially Equivalent on September 29, 1995. The device falls under product code IXC (Illuminator, Radiographic-Film), a Class I device regulated under 21 CFR 892.1890. 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
- Illuminator, Radiographic-Film
- Device Class
- Class I
- Regulation Number
- 892.1890
- Review Panel
- RA
- Submission Type