510(k) K231141

STarFix Designer Software C0265 by FHC, Inc. — Product Code QRI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 8, 2023
Date Received: April 21, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Surgical Planning Software For Neurological Stereotaxic Instruments
Device Class: Class II
Regulation Number: 882.4560
Review Panel: NE
Submission Type

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.

Other clearances by FHC, Inc.

K200169 — VFS1 Bipolar Electrosurgical Generator (May 14, 2020)
K183123 — microTargeting Guideline 4000 5.0 System (December 20, 2018)
K121950 — MICROTARGETING XL STAR DRIVE SYSTEM (July 26, 2012)
K092192 — WAYPOINT STEREOTACTIC SYSTEM (February 12, 2010)
K092562 — MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS (September 18, 2009)
K071364 — MICROTARGETING GUIDELINE 4000 (July 25, 2007)
K033173 — MICRO TARGETING ELECTRODE (March 24, 2004)
K011775 — MICRO TARGETING DRIVE SYSTEM (August 30, 2001)
K011992 — FHC MICROTARGETING DRIVE SYSTEM (August 14, 2001)
K003776 — MICROTARGETING DRIVE SYSTEM (February 23, 2001)