K896588 is an FDA 510(k) clearance for the ONCOPROBE II 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 March 14, 1990, 113 days after receiving the submission on November 21, 1989.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1320.
| 510(k) Number | K896588 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 1989 |
| Decision Date | March 14, 1990 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IZD — Probe, Uptake, Nuclear |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1320 |