# Insightec, Ltd.

- Location (FDA's records): Tirat Carmel
- FDA decisions: 5 (2004–2023): 2 510(k) clearances and 3 original PMA approvals
- Names in FDA's records: Insightec, Ltd. (2); Insightec (2); Insightec, Inc. (1)
- Product codes: PLP (2), NRZ (2), POH (1)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sonacare Medical, LLC: 1 (https://510kreport.com/company/sonacare-medical)

## Its most-cited devices
- K212150: Exablate Prostate System (2021), cited by 1

## Recent decisions
- K231378: Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 (Oct 30, 2023)
- K212150: Exablate Prostate System (Nov 23, 2021)
- P150038: Exablate (Jul 11, 2016)
- P110039: Exablate (Oct 18, 2012)
- P040003: Exablate 2000 System (Oct 22, 2004)

Source page: https://510kreport.com/company/insightec