Clearance Summary
CENTRICITY PACS IW received FDA 510(k) clearance under submission number K082318, sponsored by Ge Healthcare Dynamic Imaging Solutions. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2008-08-25.
- Submission: K082318
- Applicant / Sponsor: Ge Healthcare Dynamic Imaging Solutions
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2008-08-25
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.