QUALITY & COMPLIANCE

Last Updated:  November 20, 2023

At Aidoc®, exceptional quality is a core value. Our Quality Management System for managing the company’s different operations is designed in accordance with the framework established by the FDA Quality System Regulation (21 CFR Part 820) and ISO 13485.  Aidoc has been certified for ISO 13485:2016, which ensures our medical devices meet all quality requirements.

Aidoc manufactures and distributes AI image based medical devices, and non-medical device (report-based) solutions. 

Our Compliance department manages registrations and listings with the FDA, and all other regulatory authorities, in territories in which Aidoc holds business. For information on Aidoc’s products, cleared solutions, safe and correct usage and indications for use, please refer to  Aidoc’s 510(k) premarket notifications on FDA’s website and to the respective device user guide.

Indications for use and important user information for BriefCase-Triage: Aidoc’s triage and notification medical devices are not diagnostic software and are not intended to replace a clinician’s full interpretation of a medical image per standard of care. Clinical decisions should be taken only after evaluating the full original series in the PACS as well as other relevant information.

Indications for use and important user information for BriefCase-Quantification: Aidoc’s The Quantification devices are not intended to be used on a stand-alone basis for clinical decision-making, risk attribution or otherwise preclude clinical assessment of cases. The summary report produced by the software is a preliminary report only and is not intended to be used diagnostically. Clinical decisions should be taken only after evaluating the original image in the PACS as well as other relevant information. The measurement provided by the device is unofficial, not final, and subject to change after review by a radiologist. For final clinically approved measurements, please refer to the official radiology report.