Home / 510(k) Clearances / K231141

510(k) K231141

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

K231141 is an FDA 510(k) premarket notification submitted by FHC, Inc. for the device "STarFix Designer Software C0265". The FDA issued a decision of Substantially Equivalent on September 8, 2023. The device falls under product code QRI (Surgical Planning Software For Neurological Stereotaxic Instruments), a Class II device regulated under 21 CFR 882.4560. FHC, Inc. has at least 10 other 510(k) clearances on record.

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)

FDA data resources