Clearance Summary
THE NETWORK SYSTEM received FDA 510(k) clearance under submission number K980234, sponsored by Medical Sni , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1998-06-17.
- Submission: K980234
- Applicant / Sponsor: Medical Sni , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 1998-06-17
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.