FDA.report

510(k) K971181

Device
THE MIDVIEW-MEDCON'S DICOM VIEWER
Applicant
MEDCON LTD.
510(k) number
K971181
Product code
IZI  
Decision
Substantially Equivalent (SESE)
Decision date
1997-07-29
Date received
1997-03-31
Regulation
892.1600
Classification name
System, X-ray, Angiographic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
ELI M ORBACH
Address
Pob 6718 C/O Intl Regulatory Consultant Efrat IL 90435 90435

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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