K231141 is an FDA 510(k) clearance for the STarFix Designer Software C0265. This device is classified as a Surgical Planning Software For Neurological Stereotaxic Instruments (Class II - Special Controls, product code QRI).
Submitted by FHC, Inc. (Bowdoin, US). The FDA issued a Cleared decision on September 8, 2023, 140 days after receiving the submission on April 21, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560. A Surgical Planning Software For Neurological Stereotaxic Instruments Is Intended As A Stand-alone Software Device Used For Pre- And Intra-operative Planning Of Stereotactic Or Image-guided Surgeries..
| 510(k) Number | K231141 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 2023 |
| Decision Date | September 08, 2023 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | QRI - Surgical Planning Software For Neurological Stereotaxic Instruments |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |
| Definition | A Surgical Planning Software For Neurological Stereotaxic Instruments Is Intended As A Stand-alone Software Device Used For Pre- And Intra-operative Planning Of Stereotactic Or Image-guided Surgeries. |