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Quantum Diagnostic Exhaust for use with Quantum Dagnostic Modules
SPECTRUM MEDICAL LIMITED
QDE
In Commercial Distribution
- 05060434420817 ()
51-000051-00
- Extracorporeal blood gas/pH monitor
AI Swivel Instrument End ASSY DRG FTI Univ
Avalign Technologies, Inc.
M14150
In Commercial Distribution
- 00190776189631 ()
- Electrical-only medical device connection cable, reusable
AI Female Rotating FO Connector AIAI CABLE CONNECTOR
Avalign Technologies, Inc.
72-9831
In Commercial Distribution
- 00190776191221 ()
- Fibreoptic retractor handle
Novaloc® Retention Insert Instrument, stainless steel/AI
Institut Straumann AG
Non-invasive Instruments
In Commercial Distribution
- 07630031759146 ()
2010.741-NOV
- Dental precision attachment fitting/adjustment tool
Optiloc® Retention Insert Instrument, stainless steel/AI
Institut Straumann AG
Non-invasive Instruments
In Commercial Distribution
- 07630031759023 ()
3202.0001-OPT
- Dental precision attachment fitting/adjustment tool
DTX Studio AI SDK 1.0 for Windows 64-bit
Nobel Biocare AB
1
In Commercial Distribution
- 07332747207422 ()
301913
- Radiology DICOM image processing application software
IB Lab LAMA is a fully-automated radiological image processing software device intended to aid users in the measurement of limb-length discrepancy and quantitative knee alignment parameters on uni- and bilateral AP full leg radiographs of individuals at least 22 years of age. It should not be used in-lieu of full patient evaluation or solely relied
upon to make or confirm a diagnosis. The software device is intended to be used by healthcare professionals trained in radiology.
IB Lab LAMA is not indicated for use on radiographs on which Ankle Arthroplasties and/or Unicompartmental Knee Arthroplasties are present.
IB Lab GmbH
V1.06
In Commercial Distribution
- 09120105730730 ()
- X-ray image interpretive software
The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices.
IB Lab GmbH
V2.11
Not in Commercial Distribution
- 09120105730471 ()
- 09120105730464 ()
- X-ray image interpretive software
The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices.
IB Lab GmbH
V2.05
Not in Commercial Distribution
- 09120105730082 ()
- 09120105730037 ()
- X-ray image interpretive software
No Description
Radiobotics ApS
v.1.
In Commercial Distribution
- 05700002173614 ()
- X-ray image interpretive software