FIRST SOURCE INC.

First Source Inc. specializes in portable diagnostic x-ray system generators, including mobile units like the iQFlex M and iQFlex MD, which are designed for general radiographic imaging. Their product line also includes radiological general body-part positioners to assist in precise patient alignment during imaging, as well as DICOM-compatible image processing software (e.g., iQ View) to enhance radiology workflows and image management.

First Source Inc. is based in the United States, which means its devices are subject to U.S. regulatory frameworks, including FDA oversight. Since the company’s products are listed in the FDA’s 510(k) and UDI databases, they are designed to comply with U.S. medical device regulations, though individual device authorizations depend on FDA review processes for each product.

First Source Inc.’s devices are recorded in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. The 510(k) registry tracks Class I and Class II devices through submissions demonstrating substantial equivalence to predicate devices, while the UDI system ensures traceability and identification of devices in the supply chain, supporting post-market surveillance and compliance tracking.

First Source Inc.’s devices fall under FDA Class I (generally low-risk, with less stringent controls) and Class II (moderate-risk, requiring special controls to ensure safety and effectiveness). The classification depends on factors like the device’s intended use, potential risks, and whether it supports or is incorporated into patient-surgery procedures. For example, portable x-ray generators like the iQFlex Pro are typically Class II due to their role in diagnostic imaging.