Clearance Summary
Ilumien Optis, Optis Integrated, Optis Mobile received FDA 510(k) clearance under submission number K183320, sponsored by St. Jude Medical (Now Abbott Medical). The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2019-04-02.
- Submission: K183320
- Applicant / Sponsor: St. Jude Medical (Now Abbott Medical)
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2019-04-02
Classification & Regulation
This clearance is catalogued under FDA product code NQQ and 21 CFR 892.1560, within the Radiology review panel as a Class II device.