510(k) K231141

Device

STarFix Designer Software C0265

Applicant

FHC, Inc.

510(k) number

K231141

Product code

QRI

Decision

Substantially Equivalent (SESE)

Decision date

2023-09-08

Date received

2023-04-21

Regulation

882.4560

Classification name

Surgical Planning Software For Neurological Stereotaxic Instruments

Medical specialty

Neurology

Review panel

Neurology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No