K881305 is an FDA 510(k) clearance for the TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM. This device is classified as a System, X-ray, Tomography, Computed (Class II - Special Controls, product code JAK).
Submitted by Toshiba Medical Systems (Tustin, US). The FDA issued a Cleared decision on October 19, 1988, 205 days after receiving the submission on March 28, 1988.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1750.
| 510(k) Number | K881305 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 1988 |
| Decision Date | October 19, 1988 |
| Days to Decision | 205 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | JAK — System, X-ray, Tomography, Computed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1750 |