Clearance Summary
PANORAMIC OMEGA IMAGING TABLE received FDA 510(k) clearance under submission number K903988, sponsored by Med-Tron Products, 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 1990-10-23.
- Submission: K903988
- Applicant / Sponsor: Med-Tron Products, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 1990-10-23
Classification & Regulation
This clearance is catalogued under FDA product code IYX and 21 CFR 892.1100, within the Radiology review panel as a Class I device.