insightec.comEXABLATE 2100 SYSTEM
INSIGHTEC, LTD
Insightec
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9615058 | 3003105983 | INSIGHTEC, LTD. | 1 | N | 2026-01-01 | 5 NAHUM HETH ST. TIRAT CARMEL Haifa IL 39120 |
| 3007145736 | 3003004504 | InSightec, Inc. | 1 | Y | 2026-01-01 | 4851 Lbj Fwy Ste 300 Dallas TX US 75244 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07290015461399 | Neuro Kit 1.5T for USA - Kit for single use during a Neuro treatment guided under 1.5T MRI guidance.Kit content:Part DescriptionASC002258-AA BRAIN COIL 1.5T ASSYSET000932 INSIGHTEC NEURO DQA PHANTOM GEL SETSET400187 NEURO TREATMENT ACCESSORIES KIT | 18663922528 | info@insightec.com |
| 07290015461405 | NEURO V2 PATIENT TREAT.KITS 3T MASTER SET - Kit for 5 Neuro V2 treatments performed under 3T MRI guidance.Kit content:Part DescriptionSET000960-AA Neuro V2 kit 3T USMPR000444-AA HEAD RING SCREWS LONG (sterile) | 18663922528 | info@insightec.com |
| 07290015461429 | Neuro V2 Kit 3T for USA - Kit for single use during a Neuro V2 treatment guided under 3T MRI guidance.Kit content:Part DescriptionASM000355 PATIENT MEMBRANE PACKING ASSYSET000932 INSIGHTEC NEURO DQA PHANTOM GEL SETSET000961 EXABLATE NEURO CLEANING KITSET400189-AA NEURO TREATMENT ACCESSORIES KIT | 18663922528 | info@insightec.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 18831 | 1923807120 | P150038 | EXABLATE | POH | 2016-07-11 |
| 18831 | 1299561488 | P110039 | EXABLATE | NRZ | 2012-10-18 |
| 18831 | 1513653704 | P040003 | EXABLATE 2000 SYSTEM | NRZ | 2004-10-22 |
| 18831 | 1385897438 | K231378 | Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 | PLP | 2023-10-30 |
| 18831 | 1548708515 | K212150 | Exablate Prostate System | PLP | 2021-11-23 |
Product Codes Associated With Registrations#
PMA#
EXABLATE 2000 SYSTEM
INSIGHTEC, LTD
EXABLATE 2000, VERSION 4.22
INSIGHTEC, LTD
EXABLATE 2000
INSIGHTEC, LTD
EXABLATE 2000 MRI GUIDED FOCUSED ULTRASOUND SYSTEM
INSIGHTEC, LTD
EXABLATE 2000 SYSTEM
INSIGHTEC, LTD
PMN#
Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0
Insightec, Ltd.
Exablate Prostate System
Insightec, Inc.
MRGFUS PELVIC PA COIL MODEL 1.0
INSIGHTECH, LTD
1.5T MRGFUS PELVIC COIL
INSIGHTEC-TXSONICS, INC.
MRGFUS GENERAL PURPOSE AND BREAST COIL
INSIGHTEC TXSONICS, INC.
GUDID#
Exablate Neuro Treatment Accessories Kit - Exablate 4000
2025-05-01
7290019402558 - Transcranial, magnetic resonance, image-guided focused ultrasound (MRgFUS) system that is designed for Incisionless ablation of brain tissue.
2025-01-01
HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI) - HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI). Multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment.These are the upgrade kits for Integra headframes to allow compatibility with Insightec-made PFK
2023-06-26
HEADFRAME PFK TYPE 1.0 FDA/ROW INTEGRA (FMI) - HEADFRAME PFK TYPE 1.0 FDA/ROW INTEGRA (FMI). Multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment.These are the upgrade kits for Integra headframes to allow compatibility with Insightec-made PFK
2023-06-26
Neuro V2 cleaning kit - Single use kit for cleaning the product after a Neuro V2 clinical treatment
2018-11-29
Neuro V2 Kit 3T for USA - Kit for single use during a Neuro V2 treatment guided under 3T MRI guidance.Kit content:Part DescriptionASM000355 PATIENT MEMBRANE PACKING ASSYSET000932 INSIGHTEC NEURO DQA PHANTOM GEL SETSET000961 EXABLATE NEURO CLEANING KITSET400189-AA NEURO TREATMENT ACCESSORIES KIT
2018-11-29
NEURO V2 PATIENT TREAT.KITS 3T MASTER SET - Kit for 5 Neuro V2 treatments performed under 3T MRI guidance.Kit content:Part DescriptionSET000960-AA Neuro V2 kit 3T USMPR000444-AA HEAD RING SCREWS LONG (sterile)
2018-11-29
Neuro Kit 1.5T for USA - Kit for single use during a Neuro treatment guided under 1.5T MRI guidance.Kit content:Part DescriptionASC002258-AA BRAIN COIL 1.5T ASSYSET000932 INSIGHTEC NEURO DQA PHANTOM GEL SETSET400187 NEURO TREATMENT ACCESSORIES KIT
2018-06-07
Neuro Kit 3T for USA - Kit for single use during a Neuro treatment guided under 3T MRI guidance.Kit content:Part DescriptionASM000355 PATIENT MEMBRANE PACKING ASSYSET000932 INSIGHTEC NEURO DQA PHANTOM GEL SETSET400187 NEURO TREATMENT ACCESSORIES KIT
2018-06-07
HEAD RING SCREWS SHORT - Short single use short screws connecting stereotactic frame with patient skull during neuro MRI guided FUS treatment.
2018-06-07
HEAD RING SCREWS LONG - Single use screws connecting stereotactic frame with patient skull during neuro MRI guided FUS treatment.
2018-06-07
NEURO PATIENT TREAT.KITS 1.5T MASTER SET for USA - A Kit for 5 Neuro treatment used under 1.5T MRI guidance.Kit content:Part DescriptionSET000937-AA Neuro kit 1.5T US MPR000444-AA HEAD RING SCREWS LONG SET (sterile)
2018-06-07
NEURO PATIENT TREAT.KITS 3T MASTER SET - Kit for 5 Neuro treatments performed under 3T MRI guidance.Kit content:Part DescriptionSET000936-AA Neuro kit 3T USMPR000444-AA HEAD RING SCREWS LONG (sterile)
2018-06-07
Neuro Frame Attachment Strap - strap used for attaching the stereotactic frame to patient head during neuro FUS clinical treatment
2017-07-31
Neuro Stereotactic Frame Posts - multi use posts connecting stereotactic frame with patient skull , threw screws, during neuro MRI guided FUS treatmentStereotactic Frame Posts ASM001395 (70mmL) ASM001396 (70mmR) ASM001397 (100mmL) ASM001398 (100mmR)
2017-07-31
Neuro Stereotactic Frame Screws Set - spare screws for neuro stereotactic frame for use during neuro FUS clinical treatment
2017-07-31
Neuro Protective Frame Pin Cup - single use silicon cups to protect head membrane from tearing by stereotactic frame sharp screws during FUS neuro clinical treatment
2017-07-31
Neuro Stereotactic Frame - a multi use ASM001399 for fixing the skull position during neuro FUS clinical treatment
2017-07-31
Neuro Stereotactic Frame Set - multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment
2017-07-31
HEAD RING SCREWS SHORT - Short single use short screws connecting stereotactic frame with patient skull during neuro MRI guided FUS treatment.
2017-06-07
Neuro Helmet Sealant - Neuro Helmet Sealant for neuro FUS clinical treatment
2017-07-31
Neuro Patient Accessory Kit - a single use kit for a neuro FUS clinical treatmentcontains:Description QTY Cat. No.EXABLATE NEURO DQA PHANTOM GEL SET 1 SET000932EXABLATE NEURO ACCESSORIES SET 1 SET400187EXABLATE NEURO CLEANING KIT 1 SET000933
2017-07-31
HEAD RING SCREWS LONG - Ong single use screws connecting stereotactic frame with patient skull during neuro MRI guided FUS treatment.
2017-06-07
NEURO DQA PHANTOM GEL - DQA phantom (tissue mimic) gel for calibration prior neuro MR-guided FUS treatment.a part of 1.5T neuro kit (SET000937) and 3T neuro kit (SET000936)
2017-06-07
NEURO TREATMENT ACCESSORIES KIT - single use kit for neuro MR-guided FUS treatmentcontains:Description Cat. No.SILICON SEALANT (GREASE) BUY000180-AACLEAR SILICONE CAPS MPR001164
2017-06-07
Neuro Head coil - single use RF head coil for MRI imaging during neuro MRI-guided FUS treatment.a part of 1.5T neuro kit for USA (SET000937)
2017-06-07
Neuro membrane - neuro membrane for a FUS brain treatment to hold degassed water between transducer and skull.included in 3T Neuro kit for USA (SET000936)
2017-06-07
neuro cleaning kit for USA - single use kit for cleaning the product after a neuro clinical treatment
2017-06-30
Neuro Kit 1.5T for USA - Kit for single use during a Neuro treatment guided under 1.5T MRI guidance.Kit content:Part DescriptionASC002258-AA BRAIN COIL 1.5T ASSYMPR000444 HEAD RING SCREWS LONGSET000932 INSIGHTEC NEURO DQA PHANTOM GEL SETSET000933 EXABLATE NEURO CLEANING KITSET400187 NEURO TREATMENT ACCESSORIES KIT
2017-06-07
Neuro Kit 3T for USA - Kit for single use during a Neuro treatment guided under 3T MRI guidance.Kit content:Part DescriptionASM000355 PATIENT MEMBRANE PACKING ASSYMPR000444 HEAD RING SCREWS LONGSET000932 INSIGHTEC NEURO DQA PHANTOM GEL SETSET000933 EXABLATE NEURO CLEANING KITSET400187 NEURO TREATMENT ACCESSORIES KIT
2017-06-07
EXABLATE NEURO V2 - System for non-invasive tumor ablation within head through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS) for Siemens MRI scanners.
2018-12-13
water bag kit - water bag kit for ultrasound good transmission in bone treatment
2017-06-07
Patient accessory kit - UF/Bone1 clinical applications single use treatment kit
2017-06-07
EXABLATE NEURO - System for non-invasive tumor ablation within head through Focal Ultrasound (FUS) treatment under Magnetiv Resonance (MR) guidance (i.e. MRgFUS).
2016-08-03
EXABLATE - System for non-invasive tumor ablation through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS). Customer replaceable patient cradle.
2016-08-03
NEURO V2 PATIENT TREAT.KITS 3T MASTER SET - Kit for 5 Neuro V2 treatments performed under 3T MRI guidance.Kit content:Part DescriptionSET000960-BB Neuro V2 kit 3T USMPR000444-AA HEAD RING SCREWS LONG (sterile)
2019-08-07
Neuro V2 Kit 3T for USA - Kit for single use during a Neuro V2 treatment guided under 3T MRI guidance.Kit content:Part DescriptionASM000355 PATIENT MEMBRANE PACKING ASSYSET000932 INSIGHTEC NEURO DQA PHANTOM GEL SETSET400189-AA NEURO TREATMENT ACCESSORIES KIT
2019-08-07
NEURO-V1 3T TREAT. KITS (5 X SET400314) MASTER SET - A Kit for 5 Neuro treatment used under 3T MRI guidance.Kit content:Part DescriptionSET400314 Neuro kit 3T US MPR000444-AA HEAD RING SCREWS LONG SET (sterile)
2020-04-30
NEURO-V1 3T GE COIL PATIENT ACCESSORIES SET - Kit for single use during a Neuro treatment guided under 3T MRI guidance.Kit content:Part DescriptionASC002258-BB BRAIN COIL 3.0T ASSYSET000932 INSIGHTEC NEURO DQA PHANTOM GEL SETSET400189-AA NEURO TREATMENT ACCESSORIES KIT
2020-04-30
NEURO-V2 PATIENT 1.5T TREAT. KITS MASTER SET - Kit for 5 Neuro V2 treatments performed under 1.5T MRI guidance.Kit content:Part DescriptionSET400315-BB Neuro V2 kit 1.5T US MPR000444-AA HEAD RING SCREWS LONG (sterile)
2020-04-30