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FDA 510(k)

Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0

K-Number: K231378 · 2023-10-30

ApplicantInsightec, Ltd.
Decision Date2023-10-30
Product CodePLP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 is a medical device manufactured by Insightec, Ltd.. It received FDA 510(k) clearance on 2023-10-30 under approval number K231378. The device is classified under product code PLP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0?

Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 is a medical device that received FDA 510(k) clearance on 2023-10-30. It is manufactured by Insightec, Ltd.. The 510(k) number is K231378.

When was Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 approved by the FDA?

Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 received FDA 510(k) clearance on 2023-10-30, under approval number K231378.

What company makes Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0?

Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 is manufactured by Insightec, Ltd..

What is the FDA product code for Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0?

The FDA product code for Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 is PLP.

Related Clinical Trials

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Other Devices by Insightec, Ltd.

PMA P040003Ablation system, high intensity focused ultrasound (HIFU), MR-guided

Related Devices (Code: PLP)

K160942SonablateSonacare Medical, LLC K172285Ablatherm FusionEdap Technomed, Inc. K172721FOCAL ONEEdap Technomed, Inc. K191200TULSA-PRO SystemProfound Medical, Inc. K202286Tulsa-Pro SystemProfound Medical, Inc. K212150Exablate Prostate SystemInsightec, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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