Clearance Summary
NIO 5MP, MODEL MDNG-5121 received FDA 510(k) clearance under submission number K073205, sponsored by Barcoview, Medical Imaging Systems. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2007-12-19.
- Submission: K073205
- Applicant / Sponsor: Barcoview, Medical Imaging Systems
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2007-12-19
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.