FDA.report

510(k) K980565

Device
LD2000 SERIES
Applicant
GENERAL SCANNING, INC.
510(k) number
K980565
Product code
LMA  
Decision
Substantially Equivalent (SESE)
Decision date
1998-03-19
Date received
1998-02-13
Regulation
892.2030
Classification name
Digitizer, Image, Radiological
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
STEVEN P ZIS
Address
500 Arsenal St. Watertown MA US 02172 02172

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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