Intended Use

Web based PACS software tool including image enhancement features (window levelling, presets, inversion, MIP and MPR), spatial locator and measuring functions for the area of diagnostic radiology.

Medical Purpose

DeepUnity PACSonWEB aids diagnosis driving clinical management by assisting (nuclear) radiologists in the diagnostic process through visualization and processing (including image manipulation) of DICOM images, providing relevant information and tools for measurement, analysis and calculation of image characteristics (e.g. geometrical, annotation, Window Level, ROI Analysis, linking of either radiological images) which are potentially related to diagnostic findings.

DeepUnity PACSonWEB is intended to investigate any anatomy of the human body which is visible in medical imaging for the purpose of visualization, detection, or measurement of abnormalities/ diseases/ medical conditions.

DeepUnity PACSonWEB is also intended to be used for injury diagnosis - it can be used for any injury that can be diagnosed using medical imaging.

Non-medical Purpose

DeepUnity PACSonWEB enables healthcare professionals to view patient images, medical documents and reports from multiple departments and perform image manipulations and measurements.

The device is used by medical professionals whenever they require access to medical images and patient demographic information.

The device is used by patients to access their medical images (primarily) and to read the associated report (if available).

Indications for Use

As a distribution medium, DeepUnity PACSonWEB is used to make medical images and reports, made at a hospital or imaging institution, available to the requesting physician and/or patient over the internet.

As a diagnostic tool, DeepUnity PACSonWEB can be used by a (nuclear) radiologist to visualize and enhance available images and perform measurements in order to make a diagnosis.

Contra-indications

• Accounts are not indicated to be created for healthcare providers that are not authorized (eligible) to request a radiology study. Non-eligible healthcare providers: physical therapists, osteopaths, nursing staff, patients.

• The device is not indicated to be used with a medical (i.e. diagnostic) purpose by users who are not qualified imaging diagnosticians.

• All tools using volume-based images like MPR, 3D rendering, reformations and similar are not intended for primary diagnostic use. These tools provide additional information but should not be relied upon as the primary means of diagnosis.

• The device is suitable for use on mobile devices, such as tablets, for image review purposes. However, mobile devices must not be used for primary image interpretation.

Intended users

DeepUnity PACSonWEB is intended to be used by the following types of users:

Intended User	Non-medical purpose Yes/No	Medical purpose Yes/No	Skills/Training Needed/Comments
Medical professionals, e.g. physicians or nurses	Yes	No	Used via integration in a patient or referring physician portal for non-diagnostic purposes. No specific training necessary. User manual is integrated in the product.
Radiologist	Yes	Yes	User training
Technologist	Yes	No	-
IT Admin	Yes	No	Ability to configure the solution, administrator training
Patient	Yes	No	Used via integration in a patient or referring physician portal for non-diagnostic purposes. No specific training necessary. User manual is integrated in the product.
DH Healthcare personnel: production, R&D, service	Yes	No	-
Veterinary staff	Yes	Yes	Veterinary staff also use the software for diagnosing diseases and injuries on animals, even though that's outside the human medical focus.

Intended use environment

DeepUnity PACSonWEB is used in a clinical environment where image data, medical documents and reports need to be viewed. Moreover, it can also be accessed outside the clinical environment by patients and physicians, enabling convenient and efficient retrieval of information.

Since DeepUnity PACSonWEB is a cloud-native solution, there is no restriction to the use environment on the condition that the monitor quality and ambient light is adequate to the intended clinical usage if used for medical (i.e. diagnostic) purposes.

Here an indicative list of intended use environments:

Intended Use Environment	Yes/No	Comment
In X-ray, MRI, etc. rooms	Yes	-
Outside X-ray, MRI, etc. rooms	Yes	-
Private radiologist sites	Yes	-
Clinic	Yes	-
Imaging centre	Yes	-
Specialty departments	Yes	-
Home environment	Yes	Used by patients outside the healthcare environment.
Emergency room	Yes	-
Intensive Care Unit	Yes	-
Military environment	Yes	-
Doctor’s office	Yes	-
Telemedicine workplace	Yes	To be used with an adequate monitor and ambient light conditions for the intended clinical usage when performing a diagnosis.
Veterinary hospital and facility	Yes	No difference in source data compared to human use.

DeepUnity PACSonWEB can also be used in veterinarian environments. The assessment for the use of this software in veterinary hospitals and facilities was based on its intended functionality and the nature of veterinary environments. The software features are aligned with those typically used in both human and veterinary medical settings. No significant differences in risk were identified between these environments, as the software does not involve direct patient interaction. The regulatory assessment conducted in relation to the intended use and veterinary environments concluded that no specific regulations apply for software used in veterinary hospitals in the target markets. Consequently, the device can be used in veterinary settings without posing additional risks.

Intended Patient Population and Medical Conditions

DeepUnity PACSonWEB use is not limited to a specific patient population or medical condition.