FDA 510(k)

ViewFinder Software Version 1.1

Номер K: K223501 · 2023-04-21

Дата решения2023-04-21

Код продуктаQIH

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

ViewFinder Software Version 1.1 is the device name listed in this FDA 510(k) record. The listed applicant is Elaitra, Ltd.. It received FDA 510(k) clearance on 2023-04-21 under 510(k) number K223501. 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 ViewFinder Software Version 1.1?

ViewFinder Software Version 1.1 is a medical device that received FDA 510(k) clearance on 2023-04-21. The listed applicant is Elaitra, Ltd.. The 510(k) number is K223501.

When did ViewFinder Software Version 1.1 receive FDA 510(k) clearance?

ViewFinder Software Version 1.1 received FDA 510(k) clearance on 2023-04-21, under 510(k) number K223501.

Who is the listed applicant for ViewFinder Software Version 1.1?

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

What is the FDA product code for ViewFinder Software Version 1.1?

The FDA product code for ViewFinder Software Version 1.1 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 K261677Artificial Intelligence Renal Assessment (AIRA) Version 1Aramis Global AI Consultancies, LLC K2608794DMINVIA, LLC

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