Clearance Summary
F.A.S.T. TABLE received FDA 510(k) clearance under submission number K896583, sponsored by Oec-Diasonics, 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 1990-03-01.
- Submission: K896583
- Applicant / Sponsor: Oec-Diasonics, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1990-03-01
Classification & Regulation
This clearance is catalogued under FDA product code IXR and 21 CFR 892.1980, within the Radiology review panel as a Class II device.