Clearance Summary
FC-1000 FLUOROSCOPIC IMAGING COMPUTER received FDA 510(k) clearance under submission number K854810, sponsored by Inficon Leybold-Heraeus, 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 1986-04-15.
- Submission: K854810
- Applicant / Sponsor: Inficon Leybold-Heraeus, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 1986-04-15
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.