Chrysalis Intelligence · Sponsors · Insightec, Ltd.

Insightec, Ltd.

Tirat-Hacarmet, IL · 2 510(k) clearances · 32 PMAs

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Total clearances
2
2021-11-23 → 2023-10-30
Last 12 months
0
Product codes
1
Most recent
2023-10-30
Name variants in FDA filings: Insightec, Ltd. / Insightec, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PLP High Intensity Ultrasound System For Prostate Tissue Ablation Class II Gastroenterology, Urology 2 2023-10-30
Class III

PMA approvals (32)

Total PMA records
32
Originals + supplements
Distinct product codes
2
First decision
2020-04-14
Most recent
2026-03-23
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-03-23 P150038-S041 EXABLATE Normal 180 Day Track No User Fee POH Mr-Guided Focused Ultrasound System Unknown
2026-03-05 P150038-S042 Exablate Model 4000 Type 1.0 and 1.1 (“Exablate Neuro”; “Exablate Prime”) Real-Time Process POH Mr-Guided Focused Ultrasound System Unknown
2026-01-28 P150038-S043 Exablate Model 4000 System 30-Day Notice POH Mr-Guided Focused Ultrasound System Unknown
2025-07-23 P040003-S022 Exablate 2000 System Magnetic Resonance Guided Focused Ultrasound Ablation of Uterine Fibroids Normal 180 Day Track No User Fee NRZ Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided Unknown
2025-07-03 P150038-S037 Exablate Model 4000 Type-1 System Panel Track POH Mr-Guided Focused Ultrasound System Unknown
2025-06-03 P150038-S039 Exablate Model 4000 System Type 1.0 and 1.1 System (“Exablate Neuro”; “Exablate Prime”) Real-Time Process POH Mr-Guided Focused Ultrasound System Unknown
2025-04-04 P150038-S040 Exablate 4000; Exablate Transcarnial MRgFUS; Exablate Neuro; Exablate Prime; ExAblate Neuravive 30-Day Notice POH Mr-Guided Focused Ultrasound System Unknown
2025-04-04 P150038-S038 Exablate Model 4000 System 30-Day Notice POH Mr-Guided Focused Ultrasound System Unknown
2025-03-25 P150038-S026 Exablate Model 4000 Type 1.0 and 1.1 Systems (“Exablate Neuro”) Normal 180 Day Track No User Fee POH Mr-Guided Focused Ultrasound System Unknown
2024-10-08 P150038-S036 Exablate Neuro, Exablate Prime, Exablate Transcranial MRgFUS, Exablate Model 4000, Exablate Neuravive Normal 180 Day Track POH Mr-Guided Focused Ultrasound System Unknown
2024-02-27 P150038-S034 Exablate 30-Day Notice POH Mr-Guided Focused Ultrasound System Unknown
2024-02-26 P150038-S035 Exablate Model 4000 Type 1.0 & Type 1.1 System, Exablate Neuro 30-Day Notice POH Mr-Guided Focused Ultrasound System Unknown
2024-01-21 P150038-S033 Exablate Model 4000 Type 1.0 & Type 1.1 System (“Exablate Neuro”) Normal 180 Day Track No User Fee POH Mr-Guided Focused Ultrasound System Unknown
2024-01-08 P150038-S032 Exablate Model 4000 Type 1.0 & Type 1.1 System (Exablate Neuro) Normal 180 Day Track POH Mr-Guided Focused Ultrasound System Unknown
2023-10-12 P150038-S025 Exablate Model 400 Type 1.0 & Type 1.1 (Exablate Neuro) Normal 180 Day Track POH Mr-Guided Focused Ultrasound System Unknown
2023-07-27 P150038-S031 Exablate Model 4000 System 30-Day Notice POH Mr-Guided Focused Ultrasound System Unknown
2023-07-27 P150038-S028 Exablate Model 400 Type 1.0 & Type 1.1, Exablate Transcranial MRgFUS, Exablate Neuro, Exablate TcMRgFUS, Exablate Neurav 30-Day Notice POH Mr-Guided Focused Ultrasound System Unknown
2023-07-27 P150038-S027 Exablate Model 400 Type 1.0 & Type 1.1, Exablate Transcranial MRgFUS, Exablate Neuro, Exablate TcMRgFUS, Exablate Neurav 30-Day Notice POH Mr-Guided Focused Ultrasound System Unknown
2023-07-21 P150038-S030 Exablate Model 4000 System 30-Day Notice POH Mr-Guided Focused Ultrasound System Unknown
2023-07-21 P150038-S029 Exablate 4000 (Exablate Neuro) 30-Day Notice POH Mr-Guided Focused Ultrasound System Unknown
2023-07-18 P150038-S015 Exablate Model 4000 Type 1.0 and 1.1 Systems (“Exablate Neuro”) Normal 180 Day Track No User Fee POH Mr-Guided Focused Ultrasound System Unknown
2022-12-08 P150038-S022 Exablate 4000 System Type-1 (i.e. Type 1.0/1.1) Normal 180 Day Track POH Mr-Guided Focused Ultrasound System Unknown
2022-11-11 P150038-S024 Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) Normal 180 Day Track No User Fee POH Mr-Guided Focused Ultrasound System Unknown
2022-11-02 P150038-S023 Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) Real-Time Process POH Mr-Guided Focused Ultrasound System Unknown
2022-07-29 P150038-S018 Exablate Model 4000 Type 1.0 and 1.1 Systems Normal 180 Day Track No User Fee POH Mr-Guided Focused Ultrasound System Unknown
2022-06-07 P150038-S021 Exablate 4000 (Exablate Neuro) Real-Time Process POH Mr-Guided Focused Ultrasound System Unknown
2022-04-06 P150038-S019 Exablate Model 4000 System 30-Day Notice POH Mr-Guided Focused Ultrasound System Unknown
2022-03-31 P150038-S020 Exablate Model 4000 System 30-Day Notice POH Mr-Guided Focused Ultrasound System Unknown
2021-10-29 P150038-S014 Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) Panel Track POH Mr-Guided Focused Ultrasound System Unknown
2021-07-22 P150038-S013 Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) Normal 180 Day Track POH Mr-Guided Focused Ultrasound System Unknown
2020-11-09 P150038-S010 Exablate 4000 (“Neuro”) Type 1.0 & 1.1 Normal 180 Day Track No User Fee POH Mr-Guided Focused Ultrasound System Unknown
2020-04-14 P150038-S012 ExAblate 4000 System (Exablate Neuro or the system) Normal 180 Day Track POH Mr-Guided Focused Ultrasound System Unknown
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2023-10-30 K231378 Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 PLP Class II Gastroenterology, Urology
2021-11-23 K212150 Exablate Prostate System PLP Class II Gastroenterology, Urology
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence