Clearance Summary
M6-M received FDA 510(k) clearance under submission number K930699, sponsored by X-Cel X-Ray 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 1993-08-09.
- Submission: K930699
- Applicant / Sponsor: X-Cel X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1720
- Decision date: 1993-08-09
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.