HITACHI, LTD.

Hitachi, Ltd. specializes in two main categories: proton therapy systems, such as the PROBEAT series, which are used for advanced cancer treatment, and modular laboratory automation components. These include output units, connection modules (like the Universal Connection Module to CCM or Phadia-250 Connector), and conveyor/elevator units designed to streamline clinical workflows. The company also produces interface units, such as the cobas 8000 and cobas 6000 Connection Units, which integrate diagnostic equipment for sample and data handling.

Hitachi, Ltd. is headquartered in Japan, which means its devices are developed under Japanese regulatory standards while also being designed to comply with global requirements. Since its products are listed in the EU’s eudamed registry and the FDA’s 510(k) and UDI systems, the company ensures its devices meet international regulatory expectations for safety, performance, and quality—whether for proton therapy systems or laboratory automation components.

Hitachi, Ltd.’s devices are listed in three key registries: the EU’s eudamed (for EU market compliance), the FDA’s 510(k) premarket notification database (for US clearance), and the FDA’s Unique Device Identifier (UDI) system (for traceability and identification). These registries ensure transparency in device authorisation, help regulators track compliance, and allow healthcare providers to verify device approval status before use.

Hitachi, Ltd.’s devices fall under three regulatory classifications: Class A (typically low-risk devices), Class II (moderate-risk devices requiring special controls), and Unclassified (U) for those not fitting standard risk tiers. The classification depends on factors like intended use, risk level, and interaction with patients—such as the PROBEAT proton therapy systems (likely Class II due to their high-risk medical application) versus modular lab components (often Class A or U). This classification determines the regulatory scrutiny and documentation requirements for each device.

The FDA’s 510(k) database includes devices that require premarket notification to demonstrate substantial equivalence to a legally marketed predicate device. If Hitachi’s proton therapy systems or certain lab automation components are new designs without a direct equivalent, they may not appear in 510(k) but could still be listed in the UDI system for identification. Conversely, modular components like connection units (e.g., cobas 6000 Connection Unit) might rely on existing standards, making them eligible for 510(k) clearance if they undergo FDA review.