Clearance Summary
860 COLOR DOPPLER OR COLORVIEW 860 received FDA 510(k) clearance under submission number K861538, sponsored by Ge Medical Systems Information Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1986-08-25.
- Submission: K861538
- Applicant / Sponsor: Ge Medical Systems Information Technologies
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1986-08-25
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.