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Sign in to claim this brandHITACHI, LTD.
Japan·JP-MF-000018582
Last updated May 27, 2026
What HITACHI, LTD. makes
Hitachi, Ltd. manufactures proton therapy systems, including the PROBEAT series, which are designed for advanced cancer treatment. The company also produces modular laboratory and automation components such as output units, connection modules (e.g., UCM2, PCM2), and conveyor/elevator units for clinical workflow integration. Additional devices include interface units like the cobas 8000 and cobas 6000 connection units, which facilitate data and sample handling in diagnostic settings.
These devices are regulated under Class A, Class II, and Unclassified (U) classifications, with listings in the EU’s eudamed registry, the FDA’s 510(k) premarket notification database, and the FDA’s Unique Device Identifier (UDI) system. The company’s products are based in Japan, adhering to global regulatory standards for medical and laboratory equipment.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Hitachi, Ltd. primarily manufacture?
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.
Where is Hitachi, Ltd. based, and how does this affect its regulatory approach?
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.
Which regulatory registries list Hitachi, Ltd.’s medical devices, and why are these important?
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.
How are Hitachi, Ltd.’s devices classified under medical device regulations?
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.
Why are some of Hitachi’s devices listed in the FDA’s 510(k) database while others are not?
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.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Japan
- Address
- 1-17-1, Toranomon, Tokyo, Japan
- Website
- hitachi-hightech.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Mikimoto Takamatsu
- EUDAMED SRN
- JP-MF-000018582
- FDA FEI Number
- —
- DUNS Number
- 693002605
Catalogue (345)
Page 2 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hitachi | EUP-B712 | FDA UDI | Class II | Unknown |
| Hitachi | S21 | FDA UDI | Class II | Unknown |
| Hitachi | Prosound Alpha 7 | FDA UDI | Class II | Unknown |
| Hitachi | UST-9104-5 | FDA UDI | Class II | Unknown |
| Hitachi | EUP-CC531 | FDA UDI | Class II | Unknown |
| Hitachi | L53K | FDA UDI | Class II | Unknown |
| Hitachi | UST-5713T | FDA UDI | Class II | Unknown |
| Hitachi | EUP-OL334 | FDA UDI | Class II | Unknown |
| Hitachi | EUP-B715 | FDA UDI | Class II | Unknown |
| Hitachi | UST-5543 | FDA UDI | Class II | Unknown |
| Hitachi | S12 | FDA UDI | Class II | Unknown |
| Hitachi | ARIETTA 65 | FDA UDI | Class II | Unknown |
| Probeat | PROBEAT-FR | FDA UDI | Class II | Active |
| Hitachi | UST-9132I | FDA UDI | Class II | Unknown |
| Hitachi | Scenaria | FDA UDI | Class II | Unknown |
| Hitachi | MP-2824 | FDA UDI | Class II | Unknown |
| Hitachi | UST-5536-7.5 | FDA UDI | Class II | Unknown |
| Hitachi | C22I | FDA UDI | Class II | Unknown |
| Hitachi | UST-5534T-7.5 | FDA UDI | Class II | Unknown |
| Hitachi | EUP-S80 | FDA UDI | Class II | Unknown |
| Hitachi | EZU-PA5O-14 | FDA UDI | Class II | Unknown |
| Hitachi | MP-2445-G20/21 | FDA UDI | Class II | Unknown |
| Hitachi | UST-MC11-8731 | FDA UDI | Class II | Unknown |
| Hitachi | EUP-O732T | FDA UDI | Class II | Unknown |
| Hitachi | ARIETTA 50 | FDA UDI | Class II | Unknown |
| Hitachi | CC41R1 | FDA UDI | Class II | Unknown |
| Hitachi | S3ESL1 | FDA UDI | Class II | Unknown |
| Hitachi | UST-52114P | FDA UDI | Class II | Unknown |
| Hitachi | EUP-VV531 | FDA UDI | Class II | Unknown |
| Hitachi | MP-2794-G18 | FDA UDI | Class II | Unknown |
| Hitachi | MP-2785-G17 | FDA UDI | Class II | Unknown |
| Hitachi | S3ESL | FDA UDI | Class II | Unknown |
| Hitachi | L46K | FDA UDI | Class II | Unknown |
| Hitachi | EUP-L53L | FDA UDI | Class II | Unknown |
| Hitachi | MP-2445-G18 | FDA UDI | Class II | Unknown |
| Hitachi | PROSOUND F75 | FDA UDI | Class II | Unknown |
| Hitachi | SCENARIA View | FDA UDI | Class II | Unknown |
| Hitachi | C42 | FDA UDI | Class II | Unknown |
| Hitachi | MP-2783 | FDA UDI | Class II | Unknown |
| Hitachi | C22P | FDA UDI | Class II | Unknown |
| Probeat | PROBEAT-CR | FDA UDI | Class II | Active |
| Hitachi | MP-2748-G22 | FDA UDI | Class II | Unknown |
| Hitachi | UST-5412 | FDA UDI | Class II | Unknown |
| Hitachi | S42 | FDA UDI | Class II | Unknown |
| C23 | C23 | FDA UDI | Class II | Unknown |
| Hitachi | EZU-PA5O-18 | FDA UDI | Class II | Unknown |
| Hitachi | ETG-4000 | FDA UDI | Class II | Unknown |
| Hitachi | C252 | FDA UDI | Class II | Unknown |
| Arietta 750 | ARIETTA 750 | FDA UDI | Class II | Unknown |
| Hitachi | UST-675P | FDA UDI | Class II | Unknown |
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