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Medical Imaging with iQ
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Use of K-PACS and ConQuest
We occasionally receive requests from users about the legal status of ConQuest or K-PACS. Therefore, we would like to take this opportunity to inform you about the following:

The free DICOM viewer K-PACS is not a medical device and therefore may not be used for any diagnostic purposes. K-PACS may be used for private and scientific use only. According to the End User License Agreement of K-PACS:

“You may install and use one copy of the Software on a single computer within your organization for evaluation and testing purposes or for scientific use in acknowledged scientific institutions. The software is not a medical device and should not be used for any commercial and/or diagnostic purposes, e. g. in medical imaging centers, hospitals or veterinary clinics.”

We reserve the right to take legal action against any infringement of this agreement.

The legal status is slightly different to K-PACS.

According to the COUNCIL DIRECTIVE 93/42/EEC, Article 1, 2.(a) any device or software used in the European Union for any diagnostic or treatment purpose of medical diseases is a medical device. So any software or application to store, view and analyze medical X-rays is a medical device. According to ANNEX IX, 4.4 Rule 16, all products used to record and process X-ray images, are medical devices class IIa. That means, that only CE class IIa approved medical devices may be used to record and process X-ray generated images like CT, CR, DR, XA, XR, MX etc. A storage system to process ultrasound or MRI images would require a classification at least according to class I. ConQuest is a freeware application and NOT a medical device. ConQuest may NOT be used in the European Union for any human diagnostic or treatment process, but may be used to record and store veterinary images.

Regarding the United States of America, also FDA regulations consider any PACS for human use a medical device which requires FDA 510(k) certification. ConQuest is a freeware application and NOT a medical device.

Please note that we do not provide any technical support for either K-PACS or ConQuest.

Our commercial alternatives iQ-VIEW and iQ-WEBX are medical devices according to class IIa and come with a CE declaration of conformity as well as an FDA 510 (k) approval. They may be used to record, process, display and read any kind of human or veterinary medical DICOM images.

If you have any further questions, please feel free to contact us.