Clearance Summary
SPECTRUM MARK I SPECIAL PROCEDURES TABLE received FDA 510(k) clearance under submission number K931563, sponsored by Spectrum 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 1993-08-23.
- Submission: K931563
- Applicant / Sponsor: Spectrum X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1993-08-23
Classification & Regulation
This clearance is catalogued under FDA product code IXR and 21 CFR 892.1980, within the Radiology review panel as a Class II device.