FDA 510(k) Premarket Notification K191007: Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems

Submission Details & Decision

Normalized public record details for 510(k) notification K191007.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K191007

Applicant / Sponsor

Supersonic Imagine

Device Name

Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems

Product Code

IYN

Decision Date

2019-10-25

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Radiology (RA)

Clearance Type

Traditional

Third Party Flag

Date Received

2019-04-16

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