K881013 is an FDA 510(k) clearance for the MULTIPURPOSE DIGITAL GAMMACAMERA, GCA-602A. This device is classified as a Camera, Scintillation (gamma) (Class I - General Controls, product code IYX).
Submitted by Toshiba Medical Systems (Tustin, US). The FDA issued a Cleared decision on August 29, 1988, 172 days after receiving the submission on March 10, 1988.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1100.
| 510(k) Number | K881013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1988 |
| Decision Date | August 29, 1988 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IYX — Camera, Scintillation (gamma) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1100 |