SonialVision G4
K-Number: K190373 · 2019-03-15
ApplicantShimadzu Corporation
Decision Date2019-03-15
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SonialVision G4 is a medical device manufactured by Shimadzu Corporation. It received FDA 510(k) clearance on 2019-03-15 under approval number K190373. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SonialVision G4?
SonialVision G4 is a medical device that received FDA 510(k) clearance on 2019-03-15. It is manufactured by Shimadzu Corporation. The 510(k) number is K190373.
When was SonialVision G4 approved by the FDA?
SonialVision G4 received FDA 510(k) clearance on 2019-03-15, under approval number K190373.
What company makes SonialVision G4?
SonialVision G4 is manufactured by Shimadzu Corporation.
What is the FDA product code for SonialVision G4?
The FDA product code for SonialVision G4 is JAA.
Other Devices by Shimadzu Corporation
Related Devices (Code: JAA)
K161019Uroview FDPausch Medical GmbH
K160301Platinum dRF Imaging SystemApelem-Dms Group
K163210Philips CombiDiagnost R90Philips Medical Systems Dmc GmbH
K173395MECALL CLISIS SYSTEMS, Discovery RF180General Medical Merate S.P.A
K180651Uroview FD IIPausch Medical GmbH
K180589DR 800 with MUSICA DynamicAgfa Healthcare N.V.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.