Clearance Summary
0180 INTUITION, 0072 PRECISION received FDA 510(k) clearance under submission number K140683, sponsored by Arcoma AB. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2014-06-03.
- Submission: K140683
- Applicant / Sponsor: Arcoma AB
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2014-06-03
Classification & Regulation
This clearance is catalogued under FDA product code KPR and 21 CFR 892.1680, within the Radiology review panel as a Class II device.