Clearance Summary
SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF received FDA 510(k) clearance under submission number K901422, sponsored by Image Systems, 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 1990-08-21.
- Submission: K901422
- Applicant / Sponsor: Image Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 1990-08-21
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.