Clearance Summary
DI-2000 received FDA 510(k) clearance under submission number K943602, sponsored by Miles Inc., Agfa Division. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1995-05-12.
- Submission: K943602
- Applicant / Sponsor: Miles Inc., Agfa Division
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 1995-05-12
Classification & Regulation
This clearance is catalogued under FDA product code IYX and 21 CFR 892.1100, within the Radiology review panel as a Class I device.