Clearance Summary
PACS EQUIPMENT received FDA 510(k) clearance under submission number K943994, sponsored by Rstar Image Management System. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1995-05-12.
- Submission: K943994
- Applicant / Sponsor: Rstar Image Management System
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.2020
- Decision date: 1995-05-12
Classification & Regulation
This clearance is catalogued under FDA product code LMD and 21 CFR 892.2020, within the Radiology review panel as a Class I device.