Clearance Summary
MPG-50 X-RAY GENERATOR received FDA 510(k) clearance under submission number K873544, sponsored by Thomson-Cgr Medical 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 1987-10-26.
- Submission: K873544
- Applicant / Sponsor: Thomson-Cgr Medical Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1700
- Decision date: 1987-10-26
Classification & Regulation
This clearance is catalogued under FDA product code IZO and 21 CFR 892.1700, within the Radiology review panel as a Class I device.