Clearance Summary
IMAGER, BODY SECTION, RADIONUCLIDE received FDA 510(k) clearance under submission number K780395, sponsored by Union Carbide Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1978-03-31.
- Submission: K780395
- Applicant / Sponsor: Union Carbide Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1300
- Decision date: 1978-03-31
Classification & Regulation
This clearance is catalogued under FDA product code IYW and 21 CFR 892.1300, within the Radiology review panel as a Class I device.