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FDA 510(k)

Ultrasound System SONIMAGE MX1

K-Number: K180084 · 2018-02-08

ApplicantKonica Minolta, Inc.
Decision Date2018-02-08
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ultrasound System SONIMAGE MX1 is a medical device manufactured by Konica Minolta, Inc.. It received FDA 510(k) clearance on 2018-02-08 under approval number K180084. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultrasound System SONIMAGE MX1?

Ultrasound System SONIMAGE MX1 is a medical device that received FDA 510(k) clearance on 2018-02-08. It is manufactured by Konica Minolta, Inc.. The 510(k) number is K180084.

When was Ultrasound System SONIMAGE MX1 approved by the FDA?

Ultrasound System SONIMAGE MX1 received FDA 510(k) clearance on 2018-02-08, under approval number K180084.

What company makes Ultrasound System SONIMAGE MX1?

Ultrasound System SONIMAGE MX1 is manufactured by Konica Minolta, Inc..

What is the FDA product code for Ultrasound System SONIMAGE MX1?

The FDA product code for Ultrasound System SONIMAGE MX1 is IYO.

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Other Devices by Konica Minolta, Inc.

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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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