DeviceClearance

Histolog® Scanner (Hardware 2.4, Software 3.3)— 510(k) K241275

Substantially Equivalent

Samantree Medical SA

FDA 510(k) clearance K241275 for Histolog® Scanner (Hardware 2.4, Software 3.3), Substantially Equivalent on 2024-08-19. Applicant: Samantree Medical SA. Device class: 2.

Clearance details

Applicant
Samantree Medical SA
Product code
Code OWN
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lausanne, CH
Download summary PDFView on FDA.gov ↗

Recent devices under product code OWN

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Adverse events under product code OWN

product code OWN
Malfunction
1,286
Total
1,286

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.