Insightec L T D

FDA Filings

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

FDA Registration(s)

• Registration Number: 3007145736
• FEI Number: 3007145736
• Name: InSightec, Inc.
• Owner & Operator: INSIGHTEC, LTD.
• Contact Address: 5 NAHUM HETH ST. --; TIRAT CARMEL IL-NOTA 39120 IL
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 4851 LBJ Freeway Suite 400; Dallas, TX 75244 US

• Registration Number: 9615058
• FEI Number: 3003105983
• Name: NADIR ALIKACEM
• Owner & Operator: INSIGHTEC, LTD.
• Contact Address: 5 NAHUM HETH ST. --; TIRAT CARMEL IL-NOTA 39120 IL
• US Agent:
  • NADIR ALIKACEM
  • INSIGHTEC, INC.
  • 214 6302000
  • 214 6302900
  • nadira@insightec.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 4851 LBJ Frwy Suite 400; DALLAS, TX 75244 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 07290019402466 INSIGHTEC LTD	HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI) SET400168-AE	2023-07-04
GUDID 07290019402442 INSIGHTEC LTD	HEADFRAME PFK TYPE 1.0 FDA/ROW INTEGRA (FMI) SET400168-AD	2023-07-04
GUDID 07290019402268 INSIGHTEC LTD	EXABLATE PROSTATE Treatment master kit for V2.2 SET001653	2023-06-22
GUDID 07290019402237 INSIGHTEC LTD	Head Frame Set for Type 1.1 Systems FDA/ROW SET400168-BD	2023-06-22
GUDID 07290019402220 INSIGHTEC LTD	Head Frame Set for Type 1.0 Systems FDA/ROW SET400168-BC	2023-06-22
GUDID 07290019402213 INSIGHTEC LTD	EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL SU SET001117-SU	2023-06-22
GUDID 07290019402206 INSIGHTEC LTD	EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL SET001117	2023-06-22
GUDID 07290019402190 INSIGHTEC LTD	EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI SU SET001116-SU	2023-06-22
GUDID 07290019402183 INSIGHTEC LTD	EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI SET001116	2023-06-22
GUDID 07290019402176 INSIGHTEC LTD	EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE SU SET001115-SU	2023-06-22
GUDID 07290019402169 INSIGHTEC LTD	EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE SET001115	2023-06-22
GUDID 07290019402152 INSIGHTEC LTD	EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI SU SET001114-SU	2023-06-22
GUDID 07290019402145 INSIGHTEC LTD	EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE SET001114	2023-06-22
GUDID 07290019402138 INSIGHTEC LTD	EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI SU SET001113-SU	2023-06-22
GUDID 07290019402121 INSIGHTEC LTD	EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI SET001113	2023-06-22
GUDID 07290019402381 INSIGHTEC LTD	EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI (5) NON-CE SET001047	2023-02-23
GUDID 07290019402367 INSIGHTEC LTD	EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI (5) NON-CE SET001046	2023-02-23
GUDID 07290019402343 INSIGHTEC LTD	EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE (5) NON-CE SET001045	2023-02-23
GUDID 07290019402329 INSIGHTEC LTD	EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE (5) NON-CE SET001044	2023-02-23
GUDID 07290019402305 INSIGHTEC LTD	EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL (5) NON-CE SET001043	2023-02-23
GUDID 07290015461948 INSIGHTEC LTD	HEAD FRAME SET FOR TYPE 1.1 SYSTEMS (R20) SET400168-BB	2021-08-18
GUDID 07290015461931 INSIGHTEC LTD	HEAD FRAME SET FOR TYPE 1.0 SYSTEMS (R20) SET400168-BA	2021-08-18
GUDID 07290015461924 INSIGHTEC LTD	INSIGHTEC HEAD FRAME+INTEGRA PINS 1.0 SET SET400168-AB	2021-08-18
GUDID 07290015461917 INSIGHTEC LTD	Low Height Head Frame Set NEURO-V2 (Inegra) SET400168-AA	2021-08-18
GUDID 07290015461900 INSIGHTEC LTD	Master Treatment Kit for 3.0T (SIEMENS) Type 1.1 NonCE/FDA SET001104	2021-08-18
GUDID 07290015461894 INSIGHTEC LTD	Master Treatment Kit for 1.5T (SIEMENS) Type 1.1 NonCE/FDA SET001103	2021-08-18
GUDID 07290015461887 INSIGHTEC LTD	Master Treatment Kit for 3.0T (GE) Type 1.0& 1.1 NonCE/FDA SET001102	2021-08-18
GUDID 07290015461870 INSIGHTEC LTD	Master Treatment Kit for 1.5T (GE) Type 1.0 NonCE/FDA SET001101	2021-08-18
GUDID 07290015461863 INSIGHTEC LTD	Master Treatment Kit for 3.0T w\o Headcoil, Type 1.0& 1.1 NonCE/FDA SET001100	2021-08-18
GUDID 07290015461566 INSIGHTEC LTD	NEURO-V1 3T TREAT. KITS (5 X SET400314) MASTER SET SET001025	2020-05-08
GUDID 07290015461559 INSIGHTEC LTD	NEURO-V1 3T GE COIL PATIENT ACCESSORIES SET SET400314	2020-05-08
GUDID 07290015461542 INSIGHTEC LTD	NEURO-V2 PATIENT 1.5T TREAT. KITS MASTER SET SET001026-BB	2020-05-08
GUDID 07290015461535 INSIGHTEC LTD	NEURO V2 1.5T SI COIL PATIENT ACCESSORIES SET SET400315-BB	2020-05-08
GUDID 07290015461528 INSIGHTEC LTD	NEURO V2 PATIENT TREAT.KITS 3T MASTER SET SET000969-BB	2019-11-08
GUDID 07290015461511 INSIGHTEC LTD	Neuro V2 Kit 3T for USA SET000960-BB	2019-11-08
GUDID 07290015461504 INSIGHTEC LTD	ExAblate 2100/2100V1/2100V1-AR UPPER PELVIC COIL ASM000426-AA	2019-11-08
GUDID 07290015461498 INSIGHTEC LTD	ExAblate 2100 LOWER PELVIC COIL ASSEMBLY ASM000506-AA	2019-11-08
GUDID 07290015461481 INSIGHTEC LTD	ExAblate 2100V1 Pelvic RF Coil for 1.5T Artist MR OPT000037-AR	2019-11-08
GUDID 07290015461474 INSIGHTEC LTD	ExAblate 2100V1 Pelvic RF Coil 1.5T OPT000037	2019-11-08
GUDID 07290015461467 INSIGHTEC LTD	ExAblate 2100V1 LOWER PELVIC COIL ASSEMBLY ARTIST 1.5T ASC001361-AR	2019-11-08
GUDID 07290015461450 INSIGHTEC LTD	ExAblate 2100V1 LOWER PELVIC COIL 1.5T ASC001361	2019-11-08
GUDID 07290015461443 INSIGHTEC LTD	Neuro V2 cleaning kit SET000961	2019-11-08
GUDID 07290015461429 INSIGHTEC LTD	Neuro V2 Kit 3T for USA SET000960-AA	2019-11-08
GUDID 07290015461405 INSIGHTEC LTD	NEURO V2 PATIENT TREAT.KITS 3T MASTER SET SET000969	2019-11-08
GUDID 07290015461399 INSIGHTEC LTD	Neuro Kit 1.5T for USA SET000937-AA	2019-11-08
GUDID 07290015461382 INSIGHTEC LTD	Neuro Kit 3T for USA SET000936-AA	2019-11-08
GUDID 07290015461375 INSIGHTEC LTD	HEAD RING SCREWS SHORT MPR000445-AA	2019-11-08
GUDID 07290015461368 INSIGHTEC LTD	HEAD RING SCREWS LONG MPR000444-AA	2019-11-08
GUDID 07290015461351 INSIGHTEC LTD	NEURO PATIENT TREAT.KITS 1.5T MASTER SET for USA SET000973	2019-11-08
GUDID 07290015461344 INSIGHTEC LTD	NEURO PATIENT TREAT.KITS 3T MASTER SET SET000972	2019-11-08
GUDID 07290015461337 INSIGHTEC LTD	Neuro Frame Attachment Strap MEC001647	2019-11-08
GUDID 07290015461320 INSIGHTEC LTD	Neuro Stereotactic Frame Posts ASM001395_6_7_8	2019-11-08
GUDID 07290015461313 INSIGHTEC LTD	Neuro Stereotactic Frame Screws Set MPR001138	2019-11-08
GUDID 07290015461306 INSIGHTEC LTD	Neuro Protective Frame Pin Cup MPR001164	2019-11-08
GUDID 07290015461290 INSIGHTEC LTD	Neuro Stereotactic Frame ASM001399	2019-11-08
GUDID 07290015461283 INSIGHTEC LTD	Neuro Stereotactic Frame Set SET400168	2019-11-08
GUDID 07290015461276 INSIGHTEC LTD	HEAD RING SCREWS SHORT MPR000445	2019-11-08
GUDID 07290015461269 INSIGHTEC LTD	Patient plastic drape DTP000067	2019-11-08
GUDID 07290015461252 INSIGHTEC LTD	1L degasseed water pouch ASM001480	2019-11-08
GUDID 07290015461245 INSIGHTEC LTD	Neuro Helmet Sealant BUY000180-AA	2019-11-08
GUDID 07290015461238 INSIGHTEC LTD	Neuro Patient Accessory Kit SET400186	2019-11-08
GUDID 07290015461221 INSIGHTEC LTD	HEAD RING SCREWS LONG MPR000444	2019-11-08
GUDID 07290015461214 INSIGHTEC LTD	Exablate DQA Phantom Gel SET000885	2019-11-08
GUDID 07290015461207 INSIGHTEC LTD	NEURO DQA PHANTOM GEL SET000932	2019-11-08
GUDID 07290015461191 INSIGHTEC LTD	NEURO TREATMENT ACCESSORIES KIT SET400187	2019-11-08
GUDID 07290015461184 INSIGHTEC LTD	Neuro Head coil ASC002258-AA	2019-11-08
GUDID 07290015461177 INSIGHTEC LTD	Neuro membrane ASM000355	2019-11-08
GUDID 07290015461160 INSIGHTEC LTD	neuro cleaning kit for USA SET000933	2019-11-08
GUDID 07290015461146 INSIGHTEC LTD	Neuro Kit 1.5T for USA SET000937	2019-11-08
GUDID 07290015461122 INSIGHTEC LTD	Neuro Kit 3T for USA SET000936	2019-11-08
GUDID 07290015461115 INSIGHTEC LTD	Pelvic RF Coil ASM000956	2019-11-08
GUDID 07290015461108 INSIGHTEC LTD	Scar Patch SET000554	2019-11-08
GUDID 07290015461092 INSIGHTEC LTD	EXABLATE NEURO V2 EXABLATE 4000 Type 1.1	2019-11-08
GUDID 07290015461085 INSIGHTEC LTD	Gel Pad ASSY SET999014	2019-11-08
GUDID 07290015461054 INSIGHTEC LTD	water bag kit SET000840	2019-11-08
GUDID 07290015461047 INSIGHTEC LTD	Patient accessory kit SET000016	2019-11-08
GUDID 07290015461023 INSIGHTEC LTD	EXABLATE NEURO EXABLATE 4000 Type 1.0	2019-11-08
GUDID 07290015461016 INSIGHTEC LTD	EXABLATE EXABLATE 2100	2019-11-08
GUDID 07290015461009 INSIGHTEC LTD	EXABLATE EXABLATE 2000	2019-11-08
PMA P040003S021 INSIGHTEC, LTD	Exablate 2100/2100V1 System	2018-08-16
PMA P040003S019 INSIGHTEC, LTD	InSightec ExAblate System	2016-10-28
PMA P040003S018 INSIGHTEC, LTD	EXABLATE 2000 SYSTEM	2016-08-26
PMN P150038 | POH NADIR ALIKACEM [INSIGHTEC, LTD.]	ExAblate Neuro	2016-07-29
PMA P040003S017 INSIGHTEC, LTD	EXABLATE 2000 SYSTEM	2016-06-27
PMN P110039 | NRZ NADIR ALIKACEM [INSIGHTEC, LTD.]	P110039	2015-10-13
PMA P040003S016 INSIGHTEC, LTD	EXABLATE	2015-10-05
PMA P040003S015 INSIGHTEC, LTD	EXABLATE	2015-08-31
PMA P040003S014 INSIGHTEC, LTD	EXABLATE SYSTEM	2014-06-13
PMA P040003S013 INSIGHTEC, LTD	EXABLATE 2000/2100	2013-12-16
PMA P040003S012 INSIGHTEC, LTD	EXABLATE SYSTEM	2012-09-07
PMA P040003S011 INSIGHTEC, LTD	EXABLATE DEVICE	2012-05-01
PMA P040003S010 INSIGHTEC, LTD	EXABLATE	2011-12-08
PMA P040003S009 INSIGHTEC, LTD	EXABLATE 2000/2100 1.5 AND 3T	2011-08-09
PMA P040003S008 INSIGHTEC, LTD	EXABLATE	2010-08-23
PMA P040003S007 INSIGHTEC, LTD	EXABLATE 2100 SYSTEM	2010-04-19
PMA P040003S006 INSIGHTEC, LTD	EXABLATE 2100 SYSTEM	2009-12-22
PMA P040003S005 INSIGHTEC, LTD	EXABLATE 2000 SYSTEM	2009-03-04
PMN P040003 | NRZ NADIR ALIKACEM [INSIGHTEC, LTD.]	ExAblate	2007-11-12
PMN P040003 | LSY NADIR ALIKACEM [INSIGHTEC, LTD.]	ExAblate	2007-11-12
PMA P040003S004 INSIGHTEC, LTD	EXABLATE 2000, VERSION 4.22	2007-08-02
PMA P040003S002 INSIGHTEC, LTD	EXABLATE 2000	2007-02-27
PMA P040003S001 INSIGHTEC, LTD	EXABLATE 2000 MRI GUIDED FOCUSED ULTRASOUND SYSTEM	2005-12-30
PMA P040003 INSIGHTEC, LTD	EXABLATE 2000 SYSTEM	2004-10-22

Similar & Related FDA Registered Companies

• INSIGHTECH, LTD
• 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	2813A	INSIGHTEC LTD
CAGE Code	2813A	INSIGHTEC LTD
SEC	0001376126	INSIGHTEC LTD of ISRAEL