FDA 510(k)

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

K-Nummer: K231378 · 2023-10-30

Entscheidungsdatum2023-10-30

ProduktcodePLP

BeratungsausschussGU

EntscheidungSubstantially Equivalent

Produktübersicht

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

Häufig gestellte Fragen

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. The listed applicant is Insightec, Ltd.. The 510(k) number is K231378.

When did Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0?

The FDA 510(k) record lists Insightec, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

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Verwandte Geräte (Code: PLP)

K251910Focal One®Edap Technomed, Inc.K240296Tulsa Pro System (Pad-105)Profound Medical, Inc.K230692TULSA-PRO SystemProfound Medical, Inc.K211858TULSA-PRO SystemProfound Medical, Inc.K212150Exablate Prostate SystemInsightec, Inc.K202286Tulsa-Pro SystemProfound Medical, Inc.

Offizielle Quelle

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