FDA.report

510(k) K033637

Device
MEDICAL IMAGE DIGITIZER, MODEL 2908
Applicant
Array Corp.
510(k) number
K033637
Product code
LMA
Decision
Substantially Equivalent (SESE)
Decision date
2003-12-17
Date received
2003-11-19
Regulation
892.2030
Classification name
Digitizer, Image, Radiological
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
N
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 not indicated by FDA · openFDA JSON

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K013631EFILM VIDEOEfilm Medical, Inc.2001-11-20
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