Class Class II

Histolog® Scanner (Hardware 2.4, Software 3.3) (K241275)

K241275 2024-08-19 Traditional
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Description

Histolog® Scanner (Hardware 2.4, Software 3.3) by Samantree Medical SA, an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK241275
Clearance Date2024-08-19
Clearance TypeTraditional
Product CodeOWN
Regulation Number876.1500

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Predicate lineage for K241275

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Histolog® Scanner (Hardware 2.4, Software 3.3) (K241275) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K183640Cellvizio 100 Series Confocal laser Imaging systems and the...Mauna Kea Technologies2019

Trace the full predicate network for K241275

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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