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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: ExAblate
Classification Name: ABLATION SYSTEM, HIGH INTENSITY FOCUSED ULTRASOUND (HIFU), MR-GUIDED
Product Code: NRZ
Device Class: 3
Registered Establishment Name: INSIGHTEC, LTD.
Registered Establishment Number: 9615058
Owner/Operator: INSIGHTEC, LTD.
Owner/Operator Number: 9039651
Establishment Operations: Manufacturer
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