FDA.reportPublic FDA data

INSIGHTEC, LTD.

Matched from indexed company URL: Insightec, Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96150583003105983INSIGHTEC, LTD.1N2026-01-015 NAHUM HETH ST. TIRAT CARMEL Haifa IL 39120
30071457363003004504InSightec, Inc.1Y2026-01-014851 Lbj Fwy Ste 300 Dallas TX US 75244

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07290019402121EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI - EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI w/PFK for 5 treatments for Siemens MRPFK package served ETO-sterile18663922528info@insightec.com
07290019402138EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI SU - EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI w/PFK for 1 treatment for Siemens MRPFK package served ETO-sterile18663922528info@insightec.com
07290019402145EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE - EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE w/PFK for 5 treatments for GE MRPFK package served ETO-sterile18663922528info@insightec.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
188311923807120P150038EXABLATEPOH2016-07-11
188311299561488P110039EXABLATENRZ2012-10-18
188311513653704P040003EXABLATE 2000 SYSTEMNRZ2004-10-22
188311385897438K231378Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0PLP2023-10-30
188311548708515K212150Exablate Prostate SystemPLP2021-11-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PLP22023-10-30
NRZ22012-10-18
POH12016-07-11

PMA#

Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)

2022-11-11

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 Postapp...

Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)

2022-11-02

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/componen...

Exablate 4000 (Exablate Neuro)

2022-06-07

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/componen...

Exablate Model 4000 System

2022-03-31

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 - Manufactu...

46 records. Showing 1-40. Next

PMN#

GUDID#

81 records. Showing 1-40. Next