K241174 is an FDA 510(k) clearance for the INTRABEAM (700). This device is classified as a System, Therapeutic, X-ray (Class II - Special Controls, product code JAD).
Submitted by Carl Zeiss Meditec, AG (Oberkochen, DE). The FDA issued a Cleared decision on January 10, 2025, 259 days after receiving the submission on April 26, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5900.
| 510(k) Number | K241174 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2024 |
| Decision Date | January 10, 2025 |
| Days to Decision | 259 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 |