FDA Registration Active 🇯🇵 Japan

Sony Olympus Medical Solutions Inc.

Reg #: 3011936016 · FEI: 3011936016 · Expires 2026
Products
2
Proprietary Names
7
Establishment Types
1
Classifications
2

Registration Details

Registration Name
Sony Olympus Medical Solutions Inc.
Registration Number
3011936016
FEI Number
3011936016
Status
Active
Expiry Year
2026
Initial Importer
No
Address
4-7-1 Koyasu-machi
City
Hachioji-shi Tokyo
Country
JP

Regulatory Submissions

510(k) Number
K150377

Owner / Operator

Firm Name
Sony Olympus Medical Solutions Inc.
Operator Number
10049904
Address
4-7-1 Koyasu-machi
City
Hachioji-shi
State
Tokyo
Postal Code
192-0904
Country
JP
Correspondent
Kaoru Ichimura

US Agent

Business Name
Sony Electronics Inc
Contact Name
Julie Holodak
Address
115 West Century Road, Suite 250
City
Paramus
State
NJ
ZIP
07652
Country
US
Phone
201 3584945

Products

Device Name Product Code
Laparoscope, General & Plastic Surgery GCJ
Device, Digital Image Storage, Radiological LMB

Proprietary Names

Sony LMD-X310S LCD Monitor Sony LMD-X550S LCD Monitor Sony LMD-X550ST LCD Monitor Sony LMD-X310ST LCD Monitor LMD-XH550ST LCD Monitor LMD-XH320ST LCD Monitor HVO-4000ST 4K3D VIDEO RECORDER

Establishment Types

Export Device to the United States But Perform No Other Operation on Device