Home / Companies / InSightec, Inc.

InSightec, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
6
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K231378Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0October 30, 2023
K212150Exablate Prostate SystemNovember 23, 2021