Clearance Summary
MODIFICATION TO ACCULEAF received FDA 510(k) clearance under submission number K040553, sponsored by Direx Systems Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2004-04-01.
- Submission: K040553
- Applicant / Sponsor: Direx Systems Corp.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5710
- Decision date: 2004-04-01
Classification & Regulation
This clearance is catalogued under FDA product code IXI and 21 CFR 892.5710, within the Radiology review panel as a Class II device.