Clearance Summary
RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER received FDA 510(k) clearance under submission number K101038, sponsored by Acceletronics Digital Imaging, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2010-08-17.
- Submission: K101038
- Applicant / Sponsor: Acceletronics Digital Imaging, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5840
- Decision date: 2010-08-17
Classification & Regulation
This clearance is catalogued under FDA product code KPQ and 21 CFR 892.5840, within the Radiology review panel as a Class II device.