K032511 is an FDA 510(k) clearance for the INTUITION IMAGE. This device is classified as a System, Radiation Therapy, Charged-particle, Medical (Class II - Special Controls, product code LHN).
Submitted by Brainlab AG (Heimstetten, DE). The FDA issued a Cleared decision on January 21, 2004, 160 days after receiving the submission on August 14, 2003.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K032511 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2003 |
| Decision Date | January 21, 2004 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LHN — System, Radiation Therapy, Charged-particle, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |