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FDA 510(k)

Histolog® Scanner (Hardware 2.4, Software 3.3)

K-Number: K241275 · 2024-08-19

ApplicantSamantree Medical SA
Decision Date2024-08-19
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Histolog® Scanner (Hardware 2.4, Software 3.3) is the device name listed in this FDA 510(k) record. The listed applicant is Samantree Medical SA. It received FDA 510(k) clearance on 2024-08-19 under 510(k) number K241275. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Histolog® Scanner (Hardware 2.4, Software 3.3)?

Histolog® Scanner (Hardware 2.4, Software 3.3) is a medical device that received FDA 510(k) clearance on 2024-08-19. The listed applicant is Samantree Medical SA. The 510(k) number is K241275.

When did Histolog® Scanner (Hardware 2.4, Software 3.3) receive FDA 510(k) clearance?

Histolog® Scanner (Hardware 2.4, Software 3.3) received FDA 510(k) clearance on 2024-08-19, under 510(k) number K241275.

Who is the listed applicant for Histolog® Scanner (Hardware 2.4, Software 3.3)?

The FDA 510(k) record lists Samantree Medical SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Histolog® Scanner (Hardware 2.4, Software 3.3)?

The FDA product code for Histolog® Scanner (Hardware 2.4, Software 3.3) is OWN.

Related Devices (Code: OWN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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