At Oxipit, we are committed to the highest standards of safety, quality, and regulatory compliance in medical imaging AI. Our solutions adhere to stringent regulatory frameworks to ensure reliability, patient safety, and clinical effectiveness.
Below, you will find our conformance statements, certifications, and regulatory approvals, demonstrating our commitment to compliance with international medical device regulations. Please refer to individual certificates for details on applicable regions, intended use, and specific regulatory classifications.
For further information, or to request documentation, please contact us.
Oxipit develops AI-powered medical imaging solutions designed to assist clinicians with the interpretation of radiological studies. Our technology aims to enhance workflow efficiency, improve diagnostic accuracy, and support radiologists in delivering high-quality patient care. Oxipit solutions are intended for use by healthcare professionals and are not available for purchase by the general public. Availability varies by region, and regulatory approvals may differ across markets.
For detailed device information, including indications for use, contraindications, and warnings, please refer to the user guide prior to use. Not all features are available in all regions. Oxipit AI solutions comply with applicable regulatory requirements, including CE marking under Regulation (EU) 2017/745 where applicable.
