K113732 is an FDA 510(k) clearance for the IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE). This device is classified as a System, X-ray, Tomography, Computed (Class II - Special Controls, product code JAK).
Submitted by Brainlab AG (Feldkirchen, DE). The FDA issued a Cleared decision on May 7, 2012, 140 days after receiving the submission on December 19, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1750.
| 510(k) Number | K113732 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2011 |
| Decision Date | May 07, 2012 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAK — System, X-ray, Tomography, Computed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1750 |