Clearance Summary
CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0 received FDA 510(k) clearance under submission number K052537, sponsored by American Medical Sales, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2005-11-16.
- Submission: K052537
- Applicant / Sponsor: American Medical Sales, Inc.
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2005-11-16
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.