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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

Applicant Contact#

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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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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