Brainlab AG

FDA 510(k) & PMA Approved 기기 — 50 products

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최신 FDA 결정

유형	번호	기기명	코드	날짜	작업
510(k)	K252476	Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout	LLZ	2025-10-16	보기
510(k)	K252562	Spine & Trauma Navigation Instruments	OLO	2025-09-12	보기
510(k)	K243432	Vascular Navigation PAD 2.0; Navigation Software Vascular PAD	OWB	2025-07-22	보기
510(k)	K243142	Cranial 4Pi Immobilization	IYE	2025-06-23	보기
510(k)	K250440	RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT	MUJ	2025-06-17	보기
510(k)	K243633	Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)	QIH	2025-06-13	보기
510(k)	K242569	Mixed Reality Spine Navigation	SBF	2025-05-16	보기
510(k)	K243698	cranial 정렬 시스템, cranial 정렬 소프트웨어, LITT와 함께 사용하는 cranial 정렬 소프트웨어; Cirq cranial 생검 정렬 소프트웨어; Cirq cranial sEEG 정렬 소프트웨어; VarioGuide cranial 정렬 소프트웨어; Cirq cranial LITT 정렬 소프트웨어	HAW	2025-01-28	보기
510(k)	K240431	ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface	IYE	2024-07-24	보기
510(k)	K240701	Drill Guide; Drill Bit; Spine & Trauma Navigation	OLO	2024-05-23	보기
510(k)	K232759	Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout	LLZ	2024-05-21	보기
510(k)	K234047	Automatic Registration	OLO	2024-03-20	보기
510(k)	K223864	cranial 정렬 시스템, cranial 정렬 소프트웨어, Cirq cranial 생검 정렬 소프트웨어, Cirq cranial sEEG 정렬 소프트웨어, Varioguide cranial 정렬 소프트웨어	HAW	2023-09-09	보기
510(k)	K223553	Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine	OLO	2023-08-02	보기
510(k)	K223288	Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI	HAW	2023-07-21	보기
510(k)	K223106	Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)	QIH	2023-07-14	보기
510(k)	K231052	ExacTrac Dynamic 1.1.2	IYE	2023-05-11	보기
510(k)	K223734	ENT EM	PGW	2023-04-27	보기
510(k)	K223552	Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial	HAW	2023-04-19	보기
510(k)	K223279	RT Elements (4.0)	MUJ	2023-03-14	보기