Clearance Summary
IMPAX OT3000 ORTHOPEDIC WORKSTATION received FDA 510(k) clearance under submission number K040344, sponsored by Agfa Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2004-05-12.
- Submission: K040344
- Applicant / Sponsor: Agfa Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2004-05-12
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.