FDA.report

510(k) K071584

Device
OASIS RELEASE 1.0
Applicant
SEGAMI CORPORATION
510(k) number
K071584
Product code
LLZ  
Decision
Substantially Equivalent (SESE)
Decision date
2007-08-31
Date received
2007-06-11
Regulation
892.2050
Classification name
System, Image Processing, Radiological
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
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

Related GUDID Devices

Primary DIBrandCompanyPublished
00857198006013OasisSEGAMI CORPORATION2024-03-11
00857198006006OasisSEGAMI CORPORATION2016-03-11

Legacy Summary

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FDA Review

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