Clearance Summary
WISE IMAGE MANAGEMENT SYSTEM received FDA 510(k) clearance under submission number K971451, sponsored by O Tech, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1997-06-26.
- Submission: K971451
- Applicant / Sponsor: O Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.2010
- Decision date: 1997-06-26
Classification & Regulation
This clearance is catalogued under FDA product code LMB and 21 CFR 892.2010, within the Radiology review panel as a Class I device.