Clearance Summary
EPS received FDA 510(k) clearance under submission number K974504, sponsored by E For M Imaging Systems Div., Marquette Electronic. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1998-02-27.
- Submission: K974504
- Applicant / Sponsor: E For M Imaging Systems Div., Marquette Electronic
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 1998-02-27
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.