FDA 510(k)

Miembro Inferior AI (LLAI)

N.º K: K261641 · 2026-08-18

Fecha de decisión2026-08-18

Código de productoQIH

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Lower Limb AI (LLAI) is the device name listed in this FDA 510(k) record. The listed applicant is AI Planning Logic, Inc.. It received FDA 510(k) clearance on 2026-08-18 under 510(k) number K261641. 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 Lower Limb AI (LLAI)?

Lower Limb AI (LLAI) is a medical device that received FDA 510(k) clearance on 2026-08-18. The listed applicant is AI Planning Logic, Inc.. The 510(k) number is K261641.

When did Lower Limb AI (LLAI) receive FDA 510(k) clearance?

Lower Limb AI (LLAI) received FDA 510(k) clearance on 2026-08-18, under 510(k) number K261641.

Who is the listed applicant for Lower Limb AI (LLAI)?

The FDA 510(k) record lists AI Planning Logic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lower Limb AI (LLAI)?

The FDA product code for Lower Limb AI (LLAI) 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.