FDA.reportPublic FDA data

Aquarius 8600

Primary DI
00823073002111
Brand
Aquarius 8600
Company
Imaging Dynamics Company Ltd
Model
1717TC
Device description
Flat Panel Digital Medical X-Ray Imaging Detector.
Published
2018-11-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00823073002111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00823073002111008230730021118230730021110823073002111

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray digital imaging conversion systemAn assembly of medical devices designed to convert an existing analogue x-ray system to digital (i.e., retrofit) through the acquisition and processing of digital images using existing analogue x-ray system components. As a system it consists of both: 1) a filmless cassette-size digital detector (e.g., indirect flat panel detector); and 2) additional processing/viewing hardware [e.g., a central processing unit (CPU) with integrated software and a monitor]. Following acquisition the system is intended to also process, view, and/or store patient images as part of picture archiving and communication. It does not contain the controls for the direct operation of an x-ray imaging system.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height15.5Millimeter
Length460Millimeter
Weight4Kilogram
Width460Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
504-251-9939info@imagingdynamics.com

Regulatory Flags#

DUNS number
252909973
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00823073004016Flat Panel Fixed/Portable SystemInnovaXion2017-01-26
00823073003217Aquarius 86001417WC2018-11-27
00823073005112Aquarius 86001717WCI2018-11-28
00823073005211Aquarius 86001417WCI2018-11-28
00823073001015Xplorer 1000 Detector Head (X4C)X4C2017-01-26
00823073001022X3C Detector HeadX3C2017-01-26
00823073001039Xaminer Detector HeadX3C2017-01-26
00823073001046X3G Detector HeadX3G2017-01-26
00823073011014Xplorer 1100 Digital Radiographic System1100 X4C2017-01-26
00823073011021X3C 1100 Digital Radiographic System1100 X3C2017-01-26
00823073021013Xplorer 1500 Digital Radiographic System1500 X4C2017-01-26
00823073021020X3C 1590 Digital Radiographic System1590 X3C2017-01-26
00823073031012Xplorer 1590 Digital Radiographic System1590 X4C2017-01-26
00823073031029X3C 1600 Digital Radiographic System1600 X3C2017-01-26
00823073041011Xplorer 1600 Digital Radiographic System1600 X4C2017-01-26
00823073041028X3C 1600 Plus Digital Radiographic System1600 X3C2017-01-26
00823073051010Xplorer 1600 Plus Digital Radiographic System1600 X4C2017-01-26
00823073051027X3C 2200 Digital Radiographic System2200 X3C2017-01-26
00823073061018Xplorer 2200 Digital Radiographic System2200 X4C2017-01-26
00823073061019Xplorer 1800 Digital Radiographic System1800 X4C2017-01-26

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Primary DI, Brand, Company table
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08809413811096ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811126ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811133ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
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B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.MQB2026-04-30
08809365280001SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
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