Clearance Summary
SPECTRUM AUTOMATIC CHEST UNIT MODEL C received FDA 510(k) clearance under submission number K791811, 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 1979-10-26.
- Submission: K791811
- Applicant / Sponsor: Spectrum X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1860
- Decision date: 1979-10-26
Classification & Regulation
This clearance is catalogued under FDA product code KPX and 21 CFR 892.1860, within the Radiology review panel as a Class II device.