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FDA 510(k)

Ultrasound System SONIMAGE HS1

K-Number: K182153 · 2018-09-06

ApplicantKonica Minolta, Inc.
Decision Date2018-09-06
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ultrasound System SONIMAGE HS1 is the device name listed in this FDA 510(k) record. The listed applicant is Konica Minolta, Inc.. It received FDA 510(k) clearance on 2018-09-06 under 510(k) number K182153. 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 HS1?

Ultrasound System SONIMAGE HS1 is a medical device that received FDA 510(k) clearance on 2018-09-06. The listed applicant is Konica Minolta, Inc.. The 510(k) number is K182153.

When did Ultrasound System SONIMAGE HS1 receive FDA 510(k) clearance?

Ultrasound System SONIMAGE HS1 received FDA 510(k) clearance on 2018-09-06, under 510(k) number K182153.

Who is the listed applicant for Ultrasound System SONIMAGE HS1?

The FDA 510(k) record lists Konica Minolta, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultrasound System SONIMAGE HS1?

The FDA product code for Ultrasound System SONIMAGE HS1 is IYO.

Other records listing Konica Minolta, Inc. as applicant

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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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