Clearance Summary
DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI received FDA 510(k) clearance under submission number K062376, sponsored by Rf Systems Lab.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2006-10-27.
- Submission: K062376
- Applicant / Sponsor: Rf Systems Lab.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2006-10-27
Classification & Regulation
This clearance is catalogued under FDA product code MQB and 21 CFR 892.1680, within the Radiology review panel as a Class II device.