Clearance Summary
MD322C8 31.5 Diagnostic Imaging LCD Monitor received FDA 510(k) clearance under submission number K150145, sponsored by Nec Display Solutions , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2015-02-06.
- Submission: K150145
- Applicant / Sponsor: Nec Display Solutions , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2015-02-06
Classification & Regulation
This clearance is catalogued under FDA product code PGY and 21 CFR 892.2050, within the Radiology review panel as a Class II device.