Clearance Summary
DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME) received FDA 510(k) clearance under submission number K973411, sponsored by General Scanning, 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 1997-12-04.
- Submission: K973411
- Applicant / Sponsor: General Scanning, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2030
- Decision date: 1997-12-04
Classification & Regulation
This clearance is catalogued under FDA product code LMA and 21 CFR 892.2030, within the Radiology review panel as a Class II device.