FDA 510(k)

Imagine® Enterprise Suite

Номер K: K252634 · 2026-01-16

ЗаявительSoftlink International Private Limited

Дата решения2026-01-16

Код продуктаQIH

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

Imagine® Enterprise Suite is the device name listed in this FDA 510(k) record. The listed applicant is Softlink International Private Limited. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K252634. 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 Imagine® Enterprise Suite?

Imagine® Enterprise Suite is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Softlink International Private Limited. The 510(k) number is K252634.

When did Imagine® Enterprise Suite receive FDA 510(k) clearance?

Imagine® Enterprise Suite received FDA 510(k) clearance on 2026-01-16, under 510(k) number K252634.

Who is the listed applicant for Imagine® Enterprise Suite?

The FDA 510(k) record lists Softlink International Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Imagine® Enterprise Suite?

The FDA product code for Imagine® Enterprise Suite 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)

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