K954200 is an FDA 510(k) clearance for the VOXGRAM. This device is classified as a Film, Radiographic (Class I - General Controls, product code IWZ).
Submitted by Voxel (Laguna Hills, US). The FDA issued a Cleared decision on September 29, 1995, 23 days after receiving the submission on September 6, 1995.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1840.
| 510(k) Number | K954200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 1995 |
| Decision Date | September 29, 1995 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IWZ — Film, Radiographic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1840 |