FDA.report

510(k) K013395

Device
LIFEJET VIDEO LINK
Applicant
Ferrania S.P.A.
510(k) number
K013395
Product code
LMA
Decision
Substantially Equivalent (SESE)
Decision date
2001-10-30
Date received
2001-10-15
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
Y
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
ING. MANNELLA PAOLO
Address
57 Viale Della Liberta Ferrania, Savona IT 17014 17014

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K130406DIAGNOSTICPRO EDGEVidar Systems Corp.2013-04-29
K102476TELERADPROVidar Systems Corp.2010-10-07
K093809VIDAR DENTAL FILM DIGITIZERVidar Systems Corp.2010-01-07
K091288MEDI-6000 MEDICAL IMAGE DIGITIZERMicrotek International, Inc.2009-08-14
K063424FILM DIGITZER, MODEL 2908 MAMMO PROArray Corp.2006-12-21
K042484NAI TECH PRODUCTS MEDICAL DIGITAL RECORDERNai Technology Products2004-10-20
K033637MEDICAL IMAGE DIGITIZER, MODEL 2908Array Corp.2003-12-17
K032022DIGITAL IMAGERPyramid Medical, Inc.2003-09-02
K022810COBRASCAN CR-1 FILMLESSRadiographic Digital Imaging, Inc.2002-10-11
K021949FULCRUMHowtek, Inc.2002-08-12
K020243LASERPRO 16Eradlink, Inc.2002-03-05
K013631EFILM VIDEOEfilm Medical, Inc.2001-11-20
K011049EXPRESSSUITEVidar Systems Corp.2001-10-01