Clearance Summary
IDS4 V3.2 IMAGE DISPLAY SYSTEM received FDA 510(k) clearance under submission number K991643, sponsored by O Tech, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1999-06-08.
- Submission: K991643
- Applicant / Sponsor: O Tech, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 1999-06-08
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.