K896353 is an FDA 510(k) clearance for the GE TARGET SERIES 2. This device is classified as a System, Simulation, Radiation Therapy (Class II - Special Controls, product code KPQ).
Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on December 22, 1989, 46 days after receiving the submission on November 6, 1989.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5840.
| 510(k) Number | K896353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 1989 |
| Decision Date | December 22, 1989 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | KPQ - System, Simulation, Radiation Therapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5840 |