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Aquarius 8600 Digital Radiography Sensor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K181565

by Biokinemetrics, Inc.

Identifiers

510(k) Number
K181565 FDA 510(k)
FDA Product Code
MQB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1680 FDA 510(k)
Regulation Number
892.1680 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Aquarius 8600 Digital Radiography Sensor is a solid state X-ray imager (flat panel/digital imager) used in radiology. It is a digital radiography sensor system designed to capture, process, and store diagnostic X-ray images.

The system consists of a flat panel detector that automatically detects X-rays from an independent X-ray source (55-120 kVp, minimum 30 kW) and digitizes the signal for transfer to a PC. It is supplied as a reusable device for use in clinical settings by physicians or technologists, and has received FDA 510(k) clearance under K181565.

Frequently asked questions

What is the Aquarius 8600 Digital Radiography Sensor used for?

The Aquarius 8600 is a solid-state X-ray imager designed to capture, process, and store diagnostic X-ray images in radiology. It detects X-rays from an independent source and digitizes the signal for transfer to a PC, enabling clinical imaging workflows.

Is the Aquarius 8600 sensor reusable or single-use?

The Aquarius 8600 is supplied as a reusable device intended for repeated use in clinical settings by physicians or technologists. It is not designed for single-use disposal and must be cleaned and maintained according to manufacturer guidelines between uses.

What X-ray source specifications are compatible with the Aquarius 8600?

The Aquarius 8600 automatically detects X-rays from an independent X-ray source operating within a voltage range of 55-120 kVp and requiring a minimum power of 30 kW. It is not compatible with sources outside these parameters.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Aquarius 8600 Digital Radiography Sensor (K181565) — FDA 510 (k ..., K181565 FDA 510(k) - Aquarius 8600 Digital Radiography Sensor, Aquarius 8600 Digital Radiography Sensor — FDA K181565, Aquarius 8600 Digital Radiography Sensor 510(k) K181565 - fda.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biokinemetrics, Inc.

Sources (1)

  • FDA 510(k) K181565 24 fields · synced Sep 25, 2026