Clearance Summary
PENTAMAX 1 MODEL B TABLE SYSTEM received FDA 510(k) clearance under submission number K870707, 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 1987-05-14.
- Submission: K870707
- Applicant / Sponsor: Spectrum X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1987-05-14
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.