K162568 is an FDA 510(k) clearance for the INTRABEAM 600. This device is classified as a System, Therapeutic, X-ray (Class II - Special Controls, product code JAD).
Submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on December 15, 2016, 92 days after receiving the submission on September 14, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5900.
| 510(k) Number | K162568 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2016 |
| Decision Date | December 15, 2016 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAD — System, Therapeutic, X-ray |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5900 |