Data / Medical devices / Japan / Sony Olympus Medical Solutions Inc.
Sony Olympus Medical Solutions Inc.: FDA-registered device maker in Hachioji-shi Tokyo, Japan, 1 510(k) clearance
Sony Olympus Medical Solutions Inc. is registered with the FDA (registration 3011936016) in Hachioji-shi Tokyo, Japan. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 29, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011936016
- Address
- 4-7-1 Koyasu-machi, Hachioji-shi Tokyo, Japan, 192-0904
- Owner or operator
- Sony Olympus Medical Solutions Inc. (10049904)
- Roles
- Exporter to the US
- First device listed
- August 26, 2015
- Registered through
- 2026
- Brand names listed
- HVO-4000ST 4K3D VIDEO RECORDER, LMD-XH320ST LCD Monitor, LMD-XH550ST LCD Monitor, Sony LMD-X310S LCD Monitor, Sony LMD-X310ST LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550ST LCD Monitor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Digital Image Storage, Radiological | LMB | 1 | Exporter to the US | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 29, 2015 | K150377 | Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor | GCJ | Substantially Equivalent | Sony Electronics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Digital Image Storage, Radiological
- All makers of Laparoscope, General & Plastic Surgery
Updated July 29, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.