절제 시스템, 고강도 집중超음파 (HIFU), MR가이드
PMA 번호: P110039 · 2018-08-16
광고
기기 요약
Ablation system, high intensity focused ultrasound (HIFU), MR-guided is the device name listed in this FDA 510(k) record. The listed applicant is Insightec. It received FDA 510(k) clearance on 2018-08-16. The device is classified under product code NRZ. It was reviewed by the SU advisory panel.
자주 묻는 질문
What is the Ablation system, high intensity focused ultrasound (HIFU), MR-guided?
Ablation system, high intensity focused ultrasound (HIFU), MR-guided is a medical device that received FDA 510(k) clearance on 2018-08-16. The listed applicant is Insightec.
When did Ablation system, high intensity focused ultrasound (HIFU), MR-guided receive FDA 510(k) clearance?
The clearance date for Ablation system, high intensity focused ultrasound (HIFU), MR-guided can be found in the official FDA records.
Who is the listed applicant for Ablation system, high intensity focused ultrasound (HIFU), MR-guided?
The FDA 510(k) record lists Insightec as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ablation system, high intensity focused ultrasound (HIFU), MR-guided?
The FDA product code for Ablation system, high intensity focused ultrasound (HIFU), MR-guided is NRZ.
관련 임상시험
관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.
NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751의료 기기 인공지능 보조 유로-캠 캐터터 평가 시스템:膀胱癌 진단을 위한NOT_YET_RECRUITING
공식 출처
FDA 데이터베이스에서 보기 →FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.
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