FDA Product Code QRI: Surgical Planning Software For Neurological Stereotaxic Instruments
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.
Leading manufacturers include FHC, Inc..
1
Total
1
Cleared
140d
Avg days
2023
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Surgical Planning Software For Neurological Stereotaxic Instruments Devices (Product Code QRI)
1 devices
About Product Code QRI - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QRI since 2023, with 1 receiving FDA clearance (average review time: 140 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QRI devices are reviewed by the Neurology panel. Browse all Neurology devices →