HALO MEDICAL TECHNOLOGIES

Halo Medical Technologies specializes in two primary categories of ultrasound-related devices: rectal/vaginal ultrasound imaging transducers and general-purpose ultrasound imaging systems. These devices are designed for medical diagnostics, enabling precise imaging in specific anatomical regions or broader clinical applications.

Halo Medical Technologies is headquartered in the United States. The company’s location influences its regulatory framework, as its devices are subject to FDA oversight and classification.

Halo Medical Technologies’ devices are classified as Class II under FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

Yes, Halo Medical Technologies’ devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and other stakeholders to identify and verify specific devices.

The Class II designation for Halo Medical Technologies’ devices reflects their intended use in specialized diagnostic imaging, where they pose a moderate risk to patients. Unlike Class I devices (low risk), these require additional regulatory scrutiny—such as compliance with performance standards—to mitigate potential hazards, like misdiagnosis or improper use, while still maintaining accessibility for clinical needs.