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FDA 510(k)

Aquarius 8600 Digital Radiography Sensor

K-Number: K181565 · 2018-07-13

ApplicantBiokinemetrics, Inc.
Decision Date2018-07-13
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Biokinemetrics, Inc.. The 510(k) number is K181565.

When was Aquarius 8600 Digital Radiography Sensor approved by the FDA?

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

What company makes Aquarius 8600 Digital Radiography Sensor?

Aquarius 8600 Digital Radiography Sensor is manufactured by Biokinemetrics, Inc..

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

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

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Related PubMed Literature

PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025)

Other Devices by Biokinemetrics, 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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