Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615058

FEI Number

3003105983

Entity Name

INSIGHTEC, LTD.

City/State/Country

TIRAT CARMEL Haifa, IL

Establishment Address

5 NAHUM HETH ST., TIRAT CARMEL Haifa 39120, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INSIGHTEC (Owner Number: 9039651)

Owner / Operator Contact Address

4851 LBJ Freeway, Suite 300, Dallas, TX 75244, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231378

PMA Number

N/A

All Registered Proprietary Names

Exablate Prostate System Exablate Neuro Exablate PRIME ExAblate Exablate Prostate System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PLP	High Intensity Ultrasound System For Prostate Tissue Ablation	Gastroenterology, Urology	Class 2	876.4340	2021-12-23
POH	Mr-Guided Focused Ultrasound System	Unknown	Class 3	N/A	2016-07-29
LSY	Ultrasound, Hyperthermia, Cancer Treatment	Unknown	Class 3	N/A	2007-11-12
NRZ	Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided	Unknown	Class 3	N/A	2007-11-12
PLP	High Intensity Ultrasound System For Prostate Tissue Ablation	Gastroenterology, Urology	Class 2	876.4340	2024-06-25

Official Correspondent

Lidar Dvir

US Agent Details

Lidar Dvir Business: Insightec Email: lidard@insightec.com Phone: (214) 8464320

Related Public Records

Same Entity

INSIGHTEC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
1450662	Isomedix Operations, Inc.	Libertyville, IL, US
2951226	Focus Surgery, Inc.	Indianapolis, IN, US
3012604011	PROFOUND MEDICAL INC.	Mississauga Ontario, CA
1319639	Sterigenics U.S., LLC	Queensbury, NY, US
1287394	Edap Technomed Inc.	Austin, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615058. Last updated year: 2026. Please use registration number 9615058 when referencing this establishment in official correspondence.