FDA 510(k)

Artificial Intelligence Renal Assessment (AIRA) Version 1

Номер K: K261677 · 2026-09-15

ЗаявительAramis Global AI Consultancies, LLC

Дата решения2026-09-15

Код продуктаQIH

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

Artificial Intelligence Renal Assessment (AIRA) Version 1 is the device name listed in this FDA 510(k) record. The listed applicant is Aramis Global AI Consultancies, LLC. It received FDA 510(k) clearance on 2026-09-15 under 510(k) number K261677. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Artificial Intelligence Renal Assessment (AIRA) Version 1?

Artificial Intelligence Renal Assessment (AIRA) Version 1 is a medical device that received FDA 510(k) clearance on 2026-09-15. The listed applicant is Aramis Global AI Consultancies, LLC. The 510(k) number is K261677.

When did Artificial Intelligence Renal Assessment (AIRA) Version 1 receive FDA 510(k) clearance?

Artificial Intelligence Renal Assessment (AIRA) Version 1 received FDA 510(k) clearance on 2026-09-15, under 510(k) number K261677.

Who is the listed applicant for Artificial Intelligence Renal Assessment (AIRA) Version 1?

The FDA 510(k) record lists Aramis Global AI Consultancies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Artificial Intelligence Renal Assessment (AIRA) Version 1?

The FDA product code for Artificial Intelligence Renal Assessment (AIRA) Version 1 is QIH.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: 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 K2608794DMINVIA, LLC K261795Quicktome Software SuiteOmniscient Neurotechnology Pty, Ltd.

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