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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 a medical device manufactured by Samantree Medical SA. It received FDA 510(k) clearance on 2024-08-19 under approval 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. It is manufactured by Samantree Medical SA. The 510(k) number is K241275.

When was Histolog® Scanner (Hardware 2.4, Software 3.3) approved by the FDA?

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

What company makes Histolog® Scanner (Hardware 2.4, Software 3.3)?

Histolog® Scanner (Hardware 2.4, Software 3.3) is manufactured by Samantree Medical SA.

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 Clinical Trials

NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT04662905 Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain RECRUITING NCT02091518 Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods ENROLLING_BY_INVITATION NCT07179146 A Comparison Of Dental Arch Analysis Using 3d Digital Scanning Versus Conventional Methods In Children COMPLETED NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT07527468 HISMAR: Intraoperative Margin Assessment Using the Histolog® Scanner to Reduce Reoperation in Breast-Conserving Surgery NOT_YET_RECRUITING

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Official Source

View on FDA Database →

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

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