Updated 22 October 2026
Imaging and radiology equipment distributors in Japan: 82 licensed establishments
The Bastion Hale Distributor Index lists 82 establishments in Japan whose registry records include imaging, radiology and radiotherapy: 0 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 0 manufacturers' own import or sales entities, 0 regulatory representatives, and 82 manufacturers or exporters, out of 568 medical device establishments in Japan overall. The records come from US FDA (openFDA), MHRA UK and Health Canada, last seen on 23 October 2026.
Imaging, radiology and radiotherapy covers X-ray, ultrasound, CT, MRI, nuclear medicine and treatment systems. The Index lists these establishments because the registries contain them.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Registration holder | 17 | 21% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 72 | 88% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 19 | 23% | Registered with the US FDA as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in Japan
In Japan the marketing approval or certification is held by a Marketing Authorisation Holder (MAH) based in Japan, or by a Designated MAH acting for a foreign manufacturer. The foreign manufacturer registers separately with PMDA. An independent D-MAH keeps the approval out of the distributor's hands.
Top 0 independent imaging, radiology and radiotherapy distributors
Independent distributors only, ranked by the other manufacturers' lines they carry, then registrations held, then size.
No independent distributor is registered here yet; every establishment on record is a manufacturer or a manufacturer's own sales entity.
Include manufacturers, their own sales entities and regulatory representatives (82)
Manufacturers, companies that are a manufacturer's own import or sales arm, and regulatory representatives (authorised representatives, sponsors or registration holders with no import or distribution role). They are registered here but are not independent distributors.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS MEDICAL SYSTEMS CORP. HACHIOJI-SHI Tokyo, Hachioji-shi | Manufacturer Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 351 | 229 | 0 | 74.0 | 3/5 |
| 2 | CANON INC. Kawasaki Kanagawa | Manufacturer Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +8 more | 673 | 129 | 0 | 73.7 | 3/5 |
| 3 | FUJIFILM CORPORATION ASHIGARAKAMI-GUN Kanagawa | Manufacturer Registration holder, Manufacturer | Cardiovascular, General hospital and consumables, Gastroenterology, urology and OB/GYN +4 more | 163 | 87 | 0 | 64.7 | 3/5 |
| 4 | NIDEK CO., LTD. Gamagori | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics, Ophthalmic, Orthopaedics, spine and trauma +1 more | 113 | 57 | 0 | 58.5 | 3/5 |
| 5 | PENTAX MEDICAL CORPORATION Tokyo | Manufacturer Registration holder, Manufacturer | Cardiovascular, Ear, nose and throat, Gastroenterology, urology and OB/GYN +2 more | 52 | 51 | 0 | 54.1 | 3/5 |
| 6 | KURARAY NORITAKE DENTAL INC. Kurashiki | Manufacturer Registration holder, Manufacturer | Aesthetics, dermatology and lasers, General hospital and consumables, Dental +2 more | 258 | 50 | 0 | 58.6 | 3/5 |
| 7 | SYSMEX CORPORATION KOBE Hyogo, Kobe | Manufacturer Registration holder, Manufacturer, Exporter | In-vitro diagnostics, Imaging, radiology and radiotherapy | 96 | 42 | 0 | 60.2 | 3/5 |
| 8 | NIHON KOHDEN CORPORATION SHINJUKU-KU Tokyo, Tokyo | Manufacturer Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 92 | 33 | 0 | 57.3 | 3/5 |
| 9 | TOPCON CORPORATION TOKYO | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics, Ophthalmic, Imaging, radiology and radiotherapy +1 more | 45 | 31 | 0 | 53.5 | 3/5 |
| 10 | GE Healthcare Japan Corporation HINO-SHI Tokyo | Manufacturer Registration holder, Manufacturer | Cardiovascular, Patient monitoring and neurology, Imaging, radiology and radiotherapy +1 more | 122 | 20 | 0 | 56.5 | 3/5 |
| 11 | ITO COMPANY LIMITED Kawaguchi Saitama | Manufacturer Registration holder, Manufacturer, Exporter | Patient monitoring and neurology, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy | 68 | 17 | 0 | 52.0 | 3/5 |
| 12 | KONICA MINOLTA, INC. HACHIOJI-SHI Tokyo | Manufacturer Registration holder, Manufacturer | Imaging, radiology and radiotherapy | 76 | 16 | 0 | 53.1 | 3/5 |
| 13 | SHIMADZU CORPORATION Nakagyo-Ku | Manufacturer Registration holder, Manufacturer | Cardiovascular, Ophthalmic, Imaging, radiology and radiotherapy | 61 | 16 | 0 | 49.6 | 3/5 |
| 14 | J. MORITA MANUFACTURING CORP. Kyoto | Manufacturer Registration holder, Manufacturer | Dental, Imaging, radiology and radiotherapy | 45 | 14 | 0 | 44.1 | 3/5 |
| 15 | TAKARA BELMONT CORPORATION OSAKA | Manufacturer Registration holder, Manufacturer | Dental, Imaging, radiology and radiotherapy, Surgery and endoscopy | 15 | 6 | 0 | 41.0 | 3/5 |
| 16 | CANON ELECTRON TUBES & DEVICES CO., LTD. Otawara-shi Tochigi | Manufacturer Registration holder, Manufacturer | Imaging, radiology and radiotherapy | 7 | 5 | 0 | 34.3 | 3/5 |
| 17 | Anzai Medical Co., Ltd. SHINAGAWA-KU Tokyo | Manufacturer Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, Patient monitoring and neurology +1 more | 18 | 3 | 0 | 39.2 | 3/5 |
| 18 | J. MORITA MFG. CORP. FUSHIMI-KU Kyoto | Manufacturer Manufacturer, Exporter | Dental, Imaging, radiology and radiotherapy, Surgery and endoscopy | 22 | 3 | 0 | 37.7 | 3/5 |
| 19 | KONAN MEDICAL, INC. NISHINOMIYA Hyogo, Hyogo | Manufacturer Manufacturer | Ophthalmic, Imaging, radiology and radiotherapy | 3 | 3 | 0 | 26.6 | 3/5 |
| 20 | HOYA Corporation PENTAX Lifecare Division KURIHARA-SHI Miyagi | Manufacturer Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Ear, nose and throat +3 more | 154 | 2 | 0 | 42.7 | 3/5 |
Questions about imaging, radiology and radiotherapy distributors in Japan
How many imaging, radiology and radiotherapy distributors are there in Japan?
The Index counts 82 establishments in Japan with imaging, radiology and radiotherapy in their registry record, of which 0 are independent distributors (a channel role and no manufacturing of their own). The number comes from US FDA (openFDA), MHRA UK and Health Canada and was last refreshed on 22 October 2026.
Who can hold a imaging, radiology and radiotherapy device registration in Japan?
In Japan the marketing approval or certification is held by a Marketing Authorisation Holder (MAH) based in Japan, or by a Designated MAH acting for a foreign manufacturer. The foreign manufacturer registers separately with PMDA. An independent D-MAH keeps the approval out of the distributor's hands.
How do I find a imaging, radiology and radiotherapy distributor in Japan?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Japan to reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a imaging, radiology and radiotherapy distributor in Japan?
A company that appears in a public regulatory registry with an address in Japan and whose linked device listings fall in the imaging, radiology and radiotherapy segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in Japan
Imaging, radiology and radiotherapy in other Asia Pacific markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 77 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 18 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 17 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
Index build 22 October 2026. Each establishment is counted once per country after resolving names across sources. Named individuals are never collected.
Registry data. Bastion Hale does not vouch for any establishment.