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510(k) K241275

Histolog® Scanner (Hardware 2.4, Software 3.3) by Samantree Medical SA — Product Code OWN

K241275 is an FDA 510(k) premarket notification submitted by Samantree Medical SA for the device "Histolog® Scanner (Hardware 2.4, Software 3.3)". The FDA issued a decision of Substantially Equivalent on August 19, 2024. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2024
Date Received
May 6, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Confocal Optical Imaging
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Collection of light signals for visualization of cellular microstructures.

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FDA data resources