Clearance Summary
NovaGuide 2 Intelligent Ultrasound received FDA 510(k) clearance under submission number K213279, sponsored by Novasignal Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2022-03-02.
- Submission: K213279
- Applicant / Sponsor: Novasignal Corporation
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2022-03-02
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.