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Data / Medical devices / Japan / Field Three Corporation

Field Three Corporation: FDA-registered device maker in Chiyoda Tokyo, Japan, 1 510(k) clearance

Field Three Corporation is registered with the FDA (registration 3043512431) in Chiyoda Tokyo, Japan. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 17, 2014. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3043512431
Address
5-3-6 Sotokanda, Chiyoda Tokyo, Japan, 11354
Owner or operator
Field Three Corporation (10095248)
Roles
Exporter to the US
First device listed
February 11, 2026
Registered through
2026
Brand names listed
Optima CT580

Devices it lists

DeviceProduct codeClassRoleSource
System, X-Ray, Tomography, ComputedJAK2Exporter to the USaccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 17, 2014K132410DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 WJAKSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov

Compare with other makers

Updated January 17, 2014. 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.