Clearance Summary
ORTHO 8000 received FDA 510(k) clearance under submission number K963186, sponsored by Inner Vision Mri , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1996-11-12.
- Submission: K963186
- Applicant / Sponsor: Inner Vision Mri , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 1996-11-12
Classification & Regulation
This clearance is catalogued under FDA product code LNH and 21 CFR 892.1000, within the Radiology review panel as a Class II device.