FDA 510(k)

ExacTrac 디나믹 (2.0); ExacTrac 디나믹 surface

K-번호: K240431 · 2024-07-24

결정일2024-07-24

제품 코드IYE

자문 위원회RA

결정Substantially Equivalent

기기 요약

ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2024-07-24 under 510(k) number K240431. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface?

ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Brainlab AG. The 510(k) number is K240431.

When did ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface receive FDA 510(k) clearance?

ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface received FDA 510(k) clearance on 2024-07-24, under 510(k) number K240431.

Who is the listed applicant for ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface?

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

What is the FDA product code for ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface?

The FDA product code for ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface is IYE.

Brainlab AG를 신청인으로 등재한 기타 기록

K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout K252562Spine & Trauma Navigation Instruments K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PAD K243142뇌 4Pi 고정장치 K250440RT 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 K243633브레인랩 엘리먼츠 (7.0); 브레인랩 엘리먼츠 이미지 퍼지온 (5.0); 브레인랩 엘리먼츠 이미지 퍼지온 앵고 (1.0); 브레인랩 엘리먼츠 컨투어링 (5.0); 브레인랩 엘리먼츠 파이버트래킹 (3.0); 브레인랩 엘리먼츠 BOLD MRI 맵핑 (1.0)

50개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.