Clearance Summary
MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902 received FDA 510(k) clearance under submission number K860100, sponsored by Victoreen, 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 1986-04-22.
- Submission: K860100
- Applicant / Sponsor: Victoreen, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1940
- Decision date: 1986-04-22
Classification & Regulation
This clearance is catalogued under FDA product code LHO and 21 CFR 892.1940, within the Radiology review panel as a Class I device.