APELEM

APELEM specializes in manufacturing powered tabletop systems for basic diagnostic X-ray imaging. These devices are designed to be mounted on tables and are used in medical facilities to capture radiographic images of patients. The focus is on providing reliable, table-based X-ray solutions for common diagnostic needs.

APELEM is based in the United States, meaning its devices fall under FDA jurisdiction. Since these devices are classified as Class II, they are subject to FDA’s regulatory requirements, including mandatory registration, listing, and compliance with quality system regulations. The U.S. location also influences how the company interacts with FDA databases like the Unique Device Identifier (UDI) system for traceability.

Yes, APELEM’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This matters because the UDI system ensures traceability, transparency, and compliance tracking for medical devices in the U.S. market. Listing in this registry helps healthcare providers, regulators, and supply chain partners verify device details, recall history, and manufacturer information—critical for patient safety and operational efficiency.

APELEM’s powered tabletop diagnostic X-ray systems are classified as Class II under FDA regulations. This classification implies that while they are not considered high-risk (unlike Class III devices), they still require mandatory premarket notification (510(k)) submissions to demonstrate substantial equivalence to a predicate device. Class II devices also undergo post-market surveillance to ensure continued safety and effectiveness, balancing regulatory oversight with accessibility for common diagnostic use.