Clearance Summary
CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY received FDA 510(k) clearance under submission number K063628, sponsored by Ge Healthcare Integrated IT Solutions. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2006-12-26.
- Submission: K063628
- Applicant / Sponsor: Ge Healthcare Integrated IT Solutions
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2006-12-26
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.