K243502
- 510(k) number
- K243502
- Device name
- EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)
- Applicant
- Olympus Medical Systems Corporation JP
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-01-17
- Date received
- 2024-11-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K243502.pdf
Official FDA record: K243502
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.