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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corporation. It received FDA 510(k) clearance on 2019-03-15 under 510(k) 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. The listed applicant is Shimadzu Corporation. The 510(k) number is K190373.

When did SonialVision G4 receive FDA 510(k) clearance?

SonialVision G4 received FDA 510(k) clearance on 2019-03-15, under 510(k) number K190373.

Who is the listed applicant for SonialVision G4?

The FDA 510(k) record lists Shimadzu Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SonialVision G4?

The FDA product code for SonialVision G4 is JAA.

Other records listing Shimadzu Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JAA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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.

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