Clearance Summary
MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM received FDA 510(k) clearance under submission number K913301, sponsored by Comet North America, 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 1991-08-28.
- Submission: K913301
- Applicant / Sponsor: Comet North America, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1760
- Decision date: 1991-08-28
Classification & Regulation
This clearance is catalogued under FDA product code ITY and 21 CFR 892.1760, within the Radiology review panel as a Class I device.