FDA.reportPublic FDA data

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

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

PMN#