FDA 510(k)

超声系统 SONIMAGE MX1

K号: K180084 · 2018-02-08

决定日期2018-02-08

产品代码IYO

咨询委员会RA

决定实质等同

器械摘要

Ultrasound System SONIMAGE MX1 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 2018-02-08 under 510(k) number K180084. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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. The listed applicant is Konica Minolta, Inc.. The 510(k) number is K180084.

When did Ultrasound System SONIMAGE MX1 receive FDA 510(k) clearance?

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

Who is the listed applicant for Ultrasound System SONIMAGE MX1?

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 MX1?

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

列明Konica Minolta, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K250665SKR 3000 K241319SKR 3000 K240281骨抑制软件 K230906Konicaminolta DI-X1 K223267SKR 3000 K220993超声系统 SONIMAGE MX1

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。