Clearance Summary
IISYS PACS SYSTEM received FDA 510(k) clearance under submission number K980220, sponsored by Sterling Diagnostic Imaging, 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 1998-02-13.
- Submission: K980220
- Applicant / Sponsor: Sterling Diagnostic Imaging, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.2020
- Decision date: 1998-02-13
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.