Clearance Summary
THE MIDVIEW-MEDCON'S DICOM VIEWER received FDA 510(k) clearance under submission number K971181, sponsored by Medcon , 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 1997-07-29.
- Submission: K971181
- Applicant / Sponsor: Medcon , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1600
- Decision date: 1997-07-29
Classification & Regulation
This clearance is catalogued under FDA product code IZI and 21 CFR 892.1600, within the Radiology review panel as a Class II device.