Clearance Summary
POLYSCAN DIGITAL SCANNER received FDA 510(k) clearance under submission number K944684, sponsored by Mse Medizintechnik GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1995-05-15.
- Submission: K944684
- Applicant / Sponsor: Mse Medizintechnik GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1300
- Decision date: 1995-05-15
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.