Devices · GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC

Voluson SWIFT; Voluson SWIFT+

510(k)K230346RadiologyIYN

GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC is listed for Voluson SWIFT; Voluson SWIFT+ (K230346). The FDA list gives June 20, 2023 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is IYN. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230346

Official FDA database record

Date of final decision: June 20, 2023
Company on the FDA list: GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC
Lead panel: Radiology
Primary product code: IYN
openFDA device name for the code: System, Imaging, Pulsed Doppler, Ultrasonic
Device class: 2
Regulation number: 892.1550
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary