Clearance Summary
MED-TRON SPECT IMAGING TABLE received FDA 510(k) clearance under submission number K952701, 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 1995-07-06.
- Submission: K952701
- Applicant / Sponsor: Med-Tron Products, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1995-07-06
Classification & Regulation
This clearance is catalogued under FDA product code IZZ and 21 CFR 892.1980, within the Radiology review panel as a Class II device.