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Insightec

51 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Exablate Model 4000 Type-1 System (P150038/S037)Insightec2025-07-03
Exablate Model 4000 System Type 1.0 and 1.1 System (“Exablate Neuro”; “Exablate Prime”) (P150038/S039)Insightec2025-06-03
Exablate Model 4000 System (P150038/S038)Insightec2025-04-04
Exablate 4000; Exablate Transcarnial MRgFUS; Exablate Neuro; Exablate Prime; ExAblate Neuravive (P150038/S040)Insightec2025-04-04
Exablate Model 4000 Type 1.0 and 1.1 Systems (“Exablate Neuro”) (P150038/S026)Insightec2025-03-25
Exablate Neuro, Exablate Prime, Exablate Transcranial MRgFUS, Exablate Model 4000, Exablate Neuravive (P150038/S036)Insightec2024-10-08
Exablate (P150038/S034)Insightec2024-02-27
Exablate Model 4000 Type 1.0 & Type 1.1 System, Exablate Neuro (P150038/S035)Insightec2024-02-26
Exablate Model 4000 Type 1.0 & Type 1.1 System (“Exablate Neuro”) (P150038/S033)Insightec2024-01-21
Exablate Model 4000 Type 1.0 & Type 1.1 System (Exablate Neuro) (P150038/S032)Insightec2024-01-08
Exablate Model 400 Type 1.0 & Type 1.1 (Exablate Neuro) (P150038/S025)Insightec2023-10-12
Exablate Model 400 Type 1.0 & Type 1.1, Exablate Transcranial MRgFUS, Exablate Neuro, Exablate TcMRgFUS, Exablate Neurav (P150038/S028)Insightec2023-07-27
Exablate Model 4000 System (P150038/S031)Insightec2023-07-27
Exablate Model 400 Type 1.0 & Type 1.1, Exablate Transcranial MRgFUS, Exablate Neuro, Exablate TcMRgFUS, Exablate Neurav (P150038/S027)Insightec2023-07-27
Exablate 4000 (Exablate Neuro) (P150038/S029)Insightec2023-07-21
Exablate Model 4000 System (P150038/S030)Insightec2023-07-21
Exablate Model 4000 Type 1.0 and 1.1 Systems (“Exablate Neuro”) (P150038/S015)Insightec2023-07-18
Exablate 4000 System Type-1 (i.e. Type 1.0/1.1) (P150038/S022)Insightec2022-12-08
Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) (P150038/S024)Insightec2022-11-11
Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) (P150038/S023)Insightec2022-11-02
Exablate Model 4000 Type 1.0 and 1.1 Systems (P150038/S018)Insightec2022-07-29
Exablate 4000 (Exablate Neuro) (P150038/S021)Insightec2022-06-07
Exablate Model 4000 System (P150038/S019)Insightec2022-04-06
Exablate Model 4000 System (P150038/S020)Insightec2022-03-31
Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) (P150038/S014)Insightec2021-10-29
Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) (P150038/S013)Insightec2021-07-22
Exablate 4000 (“Neuro”) Type 1.0 & 1.1 (P150038/S010)Insightec2020-11-09
ExAblate 4000 System (Exablate Neuro or the system) (P150038/S012)Insightec2020-04-14
Exablate Model 4000 System (P150038/S009)Insightec2019-06-28
Exablate 4000 System (P150038/S011)Insightec2019-04-25
ExAblate (P150038/S006)Insightec2018-12-16
ExAblate (Model 4000) System (P150038/S008)Insightec2018-10-24
Exablate Model 4000 System (P150038/S005)Insightec2018-09-20
Exablate 2100/2100V1 System (P110039/S010)Insightec2018-08-16
Exablate 4000 System (P150038/S007)Insightec2018-05-09
Exablate 2100/2100 VI System (P110039/S008)Insightec2018-01-25
ExAblate Neuro Thalamotomy (P150038/S004)Insightec2017-10-13
ExAblate (P150038/S003)Insightec2017-06-26
EXABLATE (P150038/S002)Insightec2017-04-17
EXABLATE NEURO THALAMOTOMY (P150038/S001)Insightec2016-09-29
EXABLATE (P110039/S006)Insightec2016-08-26
EXABLATE (P150038)Insightec2016-07-11
EXABLATE (P110039/S005)Insightec2016-06-27
EXABLATE 2000/2100 (P110039/S004)Insightec2013-12-17
EXABLATE (P110039/S003)Insightec2013-08-06
INSIGHTEC EXABLATE SYSTEM (P110039/S002)Insightec2013-03-15
INSIGHTEC EXABLATE SYSTEM (P110039/S001)Insightec2013-03-15
EXABLATE (P110039)Insightec2012-10-18

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Every clearance here is in the API, with alerts when new ones post.