FDA 510(k)

AudaxCeph Cephalogram Analysis Software

N.º K: K243005 · 2025-05-30

Fecha de decisión2025-05-30

Código de productoQIH

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

AudaxCeph Cephalogram Analysis Software is the device name listed in this FDA 510(k) record. The listed applicant is Audax D.O.O.. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K243005. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AudaxCeph Cephalogram Analysis Software?

AudaxCeph Cephalogram Analysis Software is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Audax D.O.O.. The 510(k) number is K243005.

When did AudaxCeph Cephalogram Analysis Software receive FDA 510(k) clearance?

AudaxCeph Cephalogram Analysis Software received FDA 510(k) clearance on 2025-05-30, under 510(k) number K243005.

Who is the listed applicant for AudaxCeph Cephalogram Analysis Software?

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

What is the FDA product code for AudaxCeph Cephalogram Analysis Software?

The FDA product code for AudaxCeph Cephalogram Analysis Software is QIH.

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: QIH)

K260055syngo.CT Brain QuantificationSiemens Medical Solutions USA, Inc.K262390BoneXpertVisiana K261368Rapid Platform (R6.7)Ischemaview, Inc.K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics K261677Artificial Intelligence Renal Assessment (AIRA) Version 1Aramis Global AI Consultancies, LLC K2608794DMINVIA, 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.