K123917 is an FDA 510(k) clearance for the DECLIPSESPECT VIEWER. This device is classified as a Probe, Uptake, Nuclear (Class I - General Controls, product code IZD).
Submitted by Surgiceye GmbH (Munich, DE). The FDA issued a Cleared decision on January 25, 2013, 37 days after receiving the submission on December 19, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1320.
| 510(k) Number | K123917 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2012 |
| Decision Date | January 25, 2013 |
| Days to Decision | 37 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IZD — Probe, Uptake, Nuclear |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1320 |