K930273 is an FDA 510(k) clearance for the ALPHA. This device is classified as a Table, Radiographic, Non-tilting, Powered (Class II - Special Controls, product code IZZ).
Submitted by Raymax Medical Corp. (Ontario, L4l 7k5, CA). The FDA issued a Cleared decision on July 13, 1993, 175 days after receiving the submission on January 19, 1993.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1980.
| 510(k) Number | K930273 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 1993 |
| Decision Date | July 13, 1993 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IZZ — Table, Radiographic, Non-tilting, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1980 |