K993742 is an FDA 510(k) clearance for the SUPER TISSUE. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by I.Z.I. Corp. (Crofton, US). The FDA issued a Cleared decision on February 2, 2000, 90 days after receiving the submission on November 4, 1999.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K993742 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 1999 |
| Decision Date | February 02, 2000 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IYE — Accelerator, Linear, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |