FDA.report

510(k) K022810

Device
COBRASCAN CR-1 FILMLESS
Applicant
Radiographic Digital Imaging, Inc.
510(k) number
K022810
Product code
LMA
Decision
Substantially Equivalent (SESE)
Decision date
2002-10-11
Date received
2002-08-23
Regulation
892.2030
Classification name
Digitizer, Image, Radiological
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
ANALEI SAMASEIA
Address
20406 Earl St. Torrance CA US 90503 90503

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Other 510(k) Records For Product Code LMA

510(k)DeviceApplicantDecision date
K132183DICOM VIDEOBar Code Computer, Ltd.2013-10-03
K130636TELERADPRO EDGE; TELERADPRO EDGE HD-CCDVidar Systems Corp.2013-06-07
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
K021949FULCRUMHowtek, Inc.2002-08-12
K020243LASERPRO 16Eradlink, Inc.2002-03-05
K013631EFILM VIDEOEfilm Medical, Inc.2001-11-20
K013395LIFEJET VIDEO LINKFerrania S.P.A.2001-10-30
K011049EXPRESSSUITEVidar Systems Corp.2001-10-01