Clearance Summary
ECHOTECH 3D FREESCAN received FDA 510(k) clearance under submission number K980308, sponsored by Echotech 3D Imaging Systems GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1998-05-06.
- Submission: K980308
- Applicant / Sponsor: Echotech 3D Imaging Systems GmbH
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1998-05-06
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.