FDA.report

510(k) K070397

Device
DGSCOPE, RELEASE 1.0
Applicant
SEGAMI CORPORATION
510(k) number
K070397
Product code
LLZ  
Decision
Substantially Equivalent (SESE)
Decision date
2007-04-13
Date received
2007-02-12
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-B Guilford Rd. 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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