Clearance Summary
DIASUS received FDA 510(k) clearance under submission number K013142, sponsored by Dynamic Imaging , 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 2001-10-05.
- Submission: K013142
- Applicant / Sponsor: Dynamic Imaging , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2001-10-05
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.