STarFix Designer Software C0265
FDA 510(k) K231141 · FHC, Inc.
510(k) numberK231141
Submission
- Device name
- STarFix Designer Software C0265
- Applicant
- FHC, Inc.
Bowdoin, ME, US - Received
- April 21, 2023
- Decision date
- September 8, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QRI – Surgical Planning Software For Neurological Stereotaxic Instruments
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
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.
More from FHC, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K200169 | VFS1 Bipolar Electrosurgical GeneratorGEI · Traditional | 05/14/2020SE |
| K183123 | microTargeting Guideline 4000 5.0 SystemGZL · Special | 12/20/2018SE |
| K121950 | Microtargeting XL Star Drive SystemHAW · Special | 07/26/2012SE |
| K092192 | Waypoint Stereotactic SystemHAW · Traditional | 02/12/2010SE |
| K092562 | Microtargeting Star Drive System, ComponentsHAW · Special | 09/18/2009SE |
| K071364 | Microtargeting Guideline 4000GZL · Traditional | 07/25/2007SE |
| K033173 | Micro Targeting ElectrodeGZL · Traditional | 03/24/2004SE |
| K011775 | Micro Targeting Drive SystemHAW · Traditional | 08/30/2001SE |
| K011992 | FHC Microtargeting Drive SystemHAW · Special | 08/14/2001SE |
| K003776 | Microtargeting Drive SystemHAW · Traditional | 02/23/2001SE |
Questions and answers
When was STarFix Designer Software C0265 cleared by the FDA?
STarFix Designer Software C0265 (K231141) received a 510(k) decision of Substantially Equivalent on September 8, 2023, 140 days after the submission was received.
What is the product code of K231141?
The FDA product code is QRI – Surgical Planning Software For Neurological Stereotaxic Instruments, a Class II (moderate risk) device regulated under 21 CFR 882.4560.