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Imaging Research Use Only (RUO) Acknowledgment

Bioscope.ai Imaging Feature — Research Use Only (RUO) Acknowledgment

This Research Use Only Acknowledgment (“Acknowledgment”) applies to the imaging feature made available by Bioscope.ai, Inc. (“Bioscope”) within the Bioscope platform (the “Imaging Feature”). It is presented to, and must be accepted by, the health care provider or other authorized clinical user (“you”) before you upload imaging to, or use the analytical outputs of, the Imaging Feature. Please read it carefully. Accepting this Acknowledgment is required to use the Imaging Feature; you may continue to use the platform’s other features, including viewing DICOM images, without accepting it.

Research and Informational Use Only
The Imaging Feature is provided for research and informational purposes only. It has not been cleared, authorized, or approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority, and it is not intended to diagnose, treat, cure, mitigate, or prevent any disease or condition. The Imaging Feature analyzes previously acquired magnetic resonance imaging (MRI) and produces informational outputs, which may include estimated brain age, volumetric measurements, normative comparisons (such as percentiles), and highlighted regions. These outputs are exploratory, may be inaccurate or incomplete, and must not be used as a basis for diagnosis or clinical decision-making.

Not Clinical Decision Support; Not a Substitute for Professional Judgment
The Imaging Feature is not clinical decision support and is not a medical device intended to inform or direct clinical management. You remain solely and fully responsible for all clinical judgments and patient-care decisions. Any such decision must be based on your own independent professional evaluation and on validated, clinically appropriate, and (where applicable) FDA-cleared or -approved methods — not on the outputs of the Imaging Feature.

Relationship to the Radiologist’s Interpretation
Bioscope plays no part in the acquisition of the MRI or in its radiological interpretation. You are responsible for obtaining each patient’s MRI and its diagnostic interpretation through your own clinical channels — including any relationship with the radiologist, or with the provider or facility from which the MRI was ordered — independently of the Imaging Feature. The Imaging Feature is not a radiological interpretation and is not a second, confirmatory, or substitute read. It must not be relied upon in place of, or weighed against, the radiologist’s report you obtain through those channels, which remains the authoritative diagnostic interpretation.

Nature and Limitations of the Outputs
Outputs of the Imaging Feature are generated by automated and machine-learning methods that have not been separately validated or cleared for diagnostic use. Results reflect the state of the underlying models and reference data at the time of processing and may change as those models and data are updated. Outputs may vary with image quality, acquisition parameters, and other factors, and may not detect — or may misrepresent — clinically significant findings. The presence or absence of any output does not establish, rule out, or quantify the risk of any disease or condition.

Use of Data
To provide the Imaging Feature, imaging you upload and the data derived from it are processed within the Bioscope software, which includes the use of artificial intelligence. Bioscope handles this information in accordance with the Health Insurance Portability and Accountability Act (HIPAA) and its Privacy Policy, and maintains administrative, physical, and technical safeguards designed to protect it. Bioscope may retain and use this information to provide the Imaging Feature and, on a deidentified basis where applicable, for internal research, product development, model validation, and quality assurance to improve its products and services, and as otherwise permitted or required by law.

Your Responsibilities
You represent that you are a licensed health care provider (or an authorized user acting under the direction of one) and that you have the authority and any patient authorization necessary to upload the patient’s imaging to, and use it within, the Imaging Feature. You are responsible for using the Imaging Feature in a manner consistent with your professional and legal obligations and with the limitations described in this Acknowledgment, and for appropriately communicating to patients that the Imaging Feature’s outputs are informational and not diagnostic.

Availability and Changes
Use of the Imaging Feature is voluntary. Bioscope may add, change, limit, gate, or discontinue features and outputs at any time, including restricting certain outputs pending regulatory clearance. Bioscope may update this Acknowledgment from time to time; if it does, you may be asked to review and accept the updated version before continuing to use the Imaging Feature.

Acknowledgment
By accepting, I confirm that:

  • I am a licensed health care provider, or an authorized user acting under the direction of one.
  • I have read and understood this Acknowledgment.
  • I understand that the Imaging Feature is for research and informational purposes only, is not FDA-cleared or approved, and is not intended to diagnose, treat, cure, or prevent any disease or condition.
  • I understand that the Imaging Feature is not clinical decision support and is not a substitute for the radiologist’s interpretation or for my own independent professional judgment.
  • I understand that I remain solely responsible for all clinical decisions, which I will base on validated, clinically appropriate methods and not on the outputs of the Imaging Feature.
  • I understand that imaging and derived data are processed as described above, including the use of artificial intelligence, and may be used on a deidentified basis to improve Bioscope’s products and services.
  • I accept the terms of this Acknowledgment.

Last Updated: July 21, 2026