FDA.report

510(k) K043441

Device
MIRAGE, RELEASE 5.5
Applicant
SEGAMI CORPORATION
510(k) number
K043441
Product code
KPS  
Decision
Substantially Equivalent (SESE)
Decision date
2005-01-13
Date received
2004-12-14
Regulation
892.1200
Classification name
System, Tomography, Computed, Emission
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
PHILIPPE BRIANDET
Address
8325 Guilford Rd., Suite B Columbia MD US 21046 21046

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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