Clearance Summary
DIGITAL PRINTER P6000D SERIES, MODEL P6000DU received FDA 510(k) clearance under submission number K061302, sponsored by Mitsubishi Electric Corporation Kyoto Works. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2006-06-23.
- Submission: K061302
- Applicant / Sponsor: Mitsubishi Electric Corporation Kyoto Works
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2040
- Decision date: 2006-06-23
Classification & Regulation
This clearance is catalogued under FDA product code LMC and 21 CFR 892.2040, within the Radiology review panel as a Class II device.