FDA.report

510(k) K982785

Device
FILM DIGITIZER MODEL 2905
Applicant
ARRAY CORP.
510(k) number
K982785
Product code
LMA  
Decision
Substantially Equivalent (SESE)
Decision date
1998-10-15
Date received
1998-08-07
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
TAKASHI INAMI
Address
3-42-10 Yoyogi, Shibuya-Ku Tokyo JP 151-0053 151-0053

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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