Clearance Summary
AIM ACCURACY IN MARKING SYSTEM received FDA 510(k) clearance under submission number K053463, sponsored by Georgene Austria. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2006-03-07.
- Submission: K053463
- Applicant / Sponsor: Georgene Austria
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 2006-03-07
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.