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Histolog Scanner (Hardware 2.4, Software 3.3)

by Samantree Medical SA

510(k) K241275

Active European Union and United States

CE IVDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241275↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK241275 Date19 Aug 2024ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
OWN
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Histolog Scanner is a confocal optical imaging device designed for high-resolution, digital imaging of tissue specimens. It enables rapid visualization of histological features, supporting real-time assessment and decision-making in pathology, particularly in gastroenterology and urology.

The device is supplied as a combination of hardware and software, intended for use in clinical or laboratory settings. It requires single-use fluorescent histological stains for imaging fresh excised human tissue, preserving specimen integrity for further pathological analysis. Authorized under FDA 510(k) and IVDR, it operates as a Class II medical device and is not MRI-compatible. Storage and handling follow standard sterile or non-sterile protocols as specified in the instructions for use.

Other devices from Samantree Medical SA

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical specialties is the Histolog Scanner primarily intended to support in real-time tissue assessment?

    The Histolog Scanner is designed to support real-time assessment in gastroenterology and urology, enabling high-resolution imaging of tissue specimens for immediate visualization of histological features. This helps pathologists and clinicians make faster decisions during procedures like biopsies, particularly in these specialties.

  • How is the Histolog Scanner supplied, and what additional consumables are required for operation?

    The Histolog Scanner is supplied as a combination of hardware (version 2.4) and software (version 3.3). To operate, it requires single-use fluorescent histological stains for imaging fresh excised human tissue, as these stains are essential for preserving specimen integrity and enabling imaging. The device itself does not include consumables—only the stains are needed.

  • Is the Histolog Scanner reusable, or is it intended for single-use, and how should it be handled?

    The Histolog Scanner is a reusable medical device, not single-use. However, the fluorescent histological stains used for imaging tissue are single-use consumables. Handling follows standard protocols for sterile or non-sterile devices as outlined in the instructions for use, depending on the intended application and workflow.

  • What regulatory pathways has the Histolog Scanner undergone, and what classification does it hold?

    The Histolog Scanner has been authorized through FDA 510(k) clearance and IVDR (In Vitro Diagnostic Regulation) in the EU, classifying it as a Class II medical device. This means it has undergone rigorous review to ensure its safety and performance for clinical use in imaging tissue specimens.

  • Can the Histolog Scanner be used in an MRI environment, and what safety considerations should be noted?

    The Histolog Scanner is not MRI-compatible, meaning it should not be used or stored in an MRI environment. This is explicitly noted in the device description, as MRI fields could potentially interfere with its electronic components or imaging accuracy. Always follow facility protocols for non-MRI-compatible equipment.