Clearance Summary
Harmony Referral System received FDA 510(k) clearance under submission number K210396, sponsored by Topcon Healthcare Solutions EMEA Oy. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2021-09-13.
- Submission: K210396
- Applicant / Sponsor: Topcon Healthcare Solutions EMEA Oy
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2021-09-13
Classification & Regulation
This clearance is catalogued under FDA product code NFJ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.