FDA.report

510(k) K993599

Device
DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019
Applicant
VIDAR SYSTEMS CORP.
510(k) number
K993599
Product code
LMA  
Decision
Substantially Equivalent (SESE)
Decision date
2000-01-18
Date received
1999-10-25
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
MARY "PENNIE" DRINKARD
Address
460 Spring Park Pl. Herndon VA US 20170 20170

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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