FDA 510(k)

RemedyLogic AI MRI Lumbar Spine Reader

Номер K: K241108 · 2024-10-30

Дата решения2024-10-30

Код продуктаQIH

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

RemedyLogic AI MRI Lumbar Spine Reader is the device name listed in this FDA 510(k) record. The listed applicant is Remedy Logic, Inc.. It received FDA 510(k) clearance on 2024-10-30 under 510(k) number K241108. 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 RemedyLogic AI MRI Lumbar Spine Reader?

RemedyLogic AI MRI Lumbar Spine Reader is a medical device that received FDA 510(k) clearance on 2024-10-30. The listed applicant is Remedy Logic, Inc.. The 510(k) number is K241108.

When did RemedyLogic AI MRI Lumbar Spine Reader receive FDA 510(k) clearance?

RemedyLogic AI MRI Lumbar Spine Reader received FDA 510(k) clearance on 2024-10-30, under 510(k) number K241108.

Who is the listed applicant for RemedyLogic AI MRI Lumbar Spine Reader?

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

What is the FDA product code for RemedyLogic AI MRI Lumbar Spine Reader?

The FDA product code for RemedyLogic AI MRI Lumbar Spine Reader 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 K261677Artificial Intelligence Renal Assessment (AIRA) Version 1Aramis Global AI Consultancies, LLC K2608794DMINVIA, LLC

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