FDA 510(k)

FlexView Diagnostic (v1.1.20)

N.º K: K233226 · 2024-01-17

Fecha de decisión2024-01-17

Código de productoLLZ

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

FlexView Diagnostic (v1.1.20) is the device name listed in this FDA 510(k) record. The listed applicant is Radical Imaging, LLC. It received FDA 510(k) clearance on 2024-01-17 under 510(k) number K233226. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the FlexView Diagnostic (v1.1.20)?

FlexView Diagnostic (v1.1.20) is a medical device that received FDA 510(k) clearance on 2024-01-17. The listed applicant is Radical Imaging, LLC. The 510(k) number is K233226.

When did FlexView Diagnostic (v1.1.20) receive FDA 510(k) clearance?

FlexView Diagnostic (v1.1.20) received FDA 510(k) clearance on 2024-01-17, under 510(k) number K233226.

Who is the listed applicant for FlexView Diagnostic (v1.1.20)?

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

What is the FDA product code for FlexView Diagnostic (v1.1.20)?

The FDA product code for FlexView Diagnostic (v1.1.20) is LLZ.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: LLZ)

K261874Syneris PACS v.1.0.1.0Syneris K262442HipStudio AnalysisReplasia BV K261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.