Clearance Summary
G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS received FDA 510(k) clearance under submission number K902984, sponsored by Electromek Diagnostic Systems, 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 1990-10-26.
- Submission: K902984
- Applicant / Sponsor: Electromek Diagnostic Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1720
- Decision date: 1990-10-26
Classification & Regulation
This clearance is catalogued under FDA product code IZL and 21 CFR 892.1720, within the Radiology review panel as a Class II device.