Clearance Summary
Illumeo System received FDA 510(k) clearance under submission number K173588, sponsored by Philips Medical Systems Technologies , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2018-01-12.
- Submission: K173588
- Applicant / Sponsor: Philips Medical Systems Technologies , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2018-01-12
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.