Histolog® Scanner (Hardware 2.4, Software 3.3)— 510(k) K241275
Substantially EquivalentSamantree 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.
Clearance details
- Applicant
- Samantree Medical SA
- Product code
- Code OWN
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lausanne, CH
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.