FDA 510(k)

Aquarius 8600 電子射線攝影感應器

K 號：K181565 · 2018-07-13

決定日期2018-07-13

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Aquarius 8600 Digital Radiography Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Biokinemetrics, Inc.. It received FDA 510(k) clearance on 2018-07-13 under 510(k) number K181565. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aquarius 8600 Digital Radiography Sensor?

Aquarius 8600 Digital Radiography Sensor is a medical device that received FDA 510(k) clearance on 2018-07-13. The listed applicant is Biokinemetrics, Inc.. The 510(k) number is K181565.

When did Aquarius 8600 Digital Radiography Sensor receive FDA 510(k) clearance?

Aquarius 8600 Digital Radiography Sensor received FDA 510(k) clearance on 2018-07-13, under 510(k) number K181565.

Who is the listed applicant for Aquarius 8600 Digital Radiography Sensor?

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

What is the FDA product code for Aquarius 8600 Digital Radiography Sensor?

The FDA product code for Aquarius 8600 Digital Radiography Sensor is MQB.

其他以 Biokinemetrics, Inc. 為申請人之記錄

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