K191740 is an FDA 510(k) clearance for the DORO LUCENT® iXI and iMRI Headrest System. This device is classified as a Holder, Head, Neurosurgical (skull Clamp) (Class II - Special Controls, product code HBL).
Submitted by Pro-Med Instruments GmbH (Freiburg, DE). The FDA issued a Cleared decision on February 21, 2020, 235 days after receiving the submission on July 1, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4460.
| 510(k) Number | K191740 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2019 |
| Decision Date | February 21, 2020 |
| Days to Decision | 235 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBL - Holder, Head, Neurosurgical (skull Clamp) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4460 |