FDA 510(k)

SkeletonPlanner

Номер K: K260206 · 2026-07-15

Дата решения2026-07-15

Код продуктаQIH

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

SkeletonPlanner is the device name listed in this FDA 510(k) record. The listed applicant is UPlanner B.V. - Presurgeo. It received FDA 510(k) clearance on 2026-07-15 under 510(k) number K260206. 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 SkeletonPlanner?

SkeletonPlanner is a medical device that received FDA 510(k) clearance on 2026-07-15. The listed applicant is UPlanner B.V. - Presurgeo. The 510(k) number is K260206.

When did SkeletonPlanner receive FDA 510(k) clearance?

SkeletonPlanner received FDA 510(k) clearance on 2026-07-15, under 510(k) number K260206.

Who is the listed applicant for SkeletonPlanner?

The FDA 510(k) record lists UPlanner B.V. - Presurgeo as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SkeletonPlanner?

The FDA product code for SkeletonPlanner 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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