FDA.report

510(k) K980873

Device
KONICA DIRECT DIGITIZER REGIUS MODEL 330
Applicant
KONICA CORP.
510(k) number
K980873
Product code
LMA  
Decision
Substantially Equivalent (SESE)
Decision date
1998-06-19
Date received
1998-03-06
Regulation
892.2030
Classification name
Digitizer, Image, 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
RUSSELL D MUNVES
Address
The Chrysler Bldg. 405 Lexington Ave. New York NY US 10174 10174

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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