Clearance Summary
IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR received FDA 510(k) clearance under submission number K082364, sponsored by Topcon 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 2008-09-30.
- Submission: K082364
- Applicant / Sponsor: Topcon Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2008-09-30
Classification & Regulation
This clearance is catalogued under FDA product code NFJ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.