Clearance Summary
GE PRECISION MPI received FDA 510(k) clearance under submission number K033486, sponsored by Nrt-Nordisk Rontgen Teknik A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2003-11-19.
- Submission: K033486
- Applicant / Sponsor: Nrt-Nordisk Rontgen Teknik A/S
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2003-11-19
Classification & Regulation
This clearance is catalogued under FDA product code OWB and 21 CFR 892.1650, within the Radiology review panel as a Class II device.