K922117 is an FDA 510(k) clearance for the C-TRAK BIOPSY SYSTEM. This device is classified as a Probe, Uptake, Nuclear (Class I - General Controls, product code IZD).
Submitted by Care Wise Medical Products Corp. (Morgan Hill, US). The FDA issued a Cleared decision on October 14, 1992, 162 days after receiving the submission on May 5, 1992.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1320.
| 510(k) Number | K922117 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 1992 |
| Decision Date | October 14, 1992 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IZD — Probe, Uptake, Nuclear |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1320 |