Clearance Summary
POLYSCAN DIGITAL SCANNER received FDA 510(k) clearance under submission number K882453, sponsored by Medical and Scientific Enterprises, 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 1988-11-23.
- Submission: K882453
- Applicant / Sponsor: Medical and Scientific Enterprises, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1300
- Decision date: 1988-11-23
Classification & Regulation
This clearance is catalogued under FDA product code IYW and 21 CFR 892.1300, within the Radiology review panel as a Class I device.