Clearance Summary
ADVIEWER 2000 received FDA 510(k) clearance under submission number K952188, sponsored by Adp , 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 1995-05-30.
- Submission: K952188
- Applicant / Sponsor: Adp , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1890
- Decision date: 1995-05-30
Classification & Regulation
This clearance is catalogued under FDA product code IXC and 21 CFR 892.1890, within the Radiology review panel as a Class I device.