Insightec

FDA Filings

This page includes the latest FDA filings for Insightec. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMA P150038S014 InSightec	Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)	2021-10-29
PMA P150038S013 InSightec	Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)	2021-07-22
PMA P150038S012 InSightec	ExAblate 4000 System (Exablate Neuro or the system)	2020-04-14
PMA P150038S011 InSightec	Exablate 4000 System	2019-04-25
PMA P150038S006 InSightec	ExAblate	2018-12-16
PMA P150038S008 InSightec	ExAblate (Model 4000) System	2018-10-24
PMA P150038S005 InSightec	Exablate Model 4000 System	2018-09-20
PMA P110039S010 InSightec	Exablate 2100/2100V1 System	2018-08-16
PMA P150038S007 InSightec	Exablate 4000 System	2018-05-09
PMA P110039S008 InSightec	Exablate 2100/2100 VI System	2018-01-25
PMA P150038S004 InSightec	ExAblate Neuro Thalamotomy	2017-10-13
PMA P150038S003 InSightec	ExAblate	2017-06-26
PMA P150038S002 InSightec	EXABLATE	2017-04-17
PMA P150038S001 InSightec	EXABLATE NEURO THALAMOTOMY	2016-09-29
PMA P110039S006 InSightec	EXABLATE	2016-08-26
PMA P150038 InSightec	EXABLATE	2016-07-11
PMA P110039S005 InSightec	EXABLATE	2016-06-27
PMA P110039S004 InSightec	EXABLATE 2000/2100	2013-12-17
PMA P110039S003 InSightec	EXABLATE	2013-08-06
PMA P110039S002 InSightec	INSIGHTEC EXABLATE SYSTEM	2013-03-15
PMA P110039S001 InSightec	INSIGHTEC EXABLATE SYSTEM	2013-03-15
PMA P110039 InSightec	EXABLATE	2012-10-18

Similar & Related FDA Registered Companies

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InSightec5 Nahum Heth Streettirat-hacarmet 39120 PMA NumberP150038 Supplement NumberS024 Date Received10/12/2022 Decision Date11/11/2022 Product Code POH Advisory Committee Neurology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
InSightec5 Nahum Heth Streettirat-hacarmet 39120 PMA NumberP150038 Supplement NumberS023 Date Received08/05/2022 Decision Date11/02/2022 Product Code POH Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
InSightec5 Nahum Heth Streettirat-hacarmet 39120 PMA NumberP150038 Supplement NumberS021 Date Received03/10/2022 Decision Date06/07/2022 Product Code POH Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
InSightec5 Nahum Heth Streettirat-hacarmet 39120 PMA NumberP150038 Supplement NumberS020 Date Received03/08/2022 Decision Date03/31/2022 Product Code POH Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	SJH93	INSIGHTEC
CAGE Code	SJH93	INSIGHTEC INSIGHTEC - IMAGE GUIDED TREATMENT LTD - FORMERLY