Clearance Summary
Voluson SWIFT; Voluson SWIFT+ received FDA 510(k) clearance under submission number K230346, sponsored by Ge Medical Systems Ultrasound & Primary Care Diagnostic, 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 2023-06-20.
- Submission: K230346
- Applicant / Sponsor: Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2023-06-20
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.