FDA.reportPublic FDA data

510(k) K021949

Device
FULCRUM
Applicant
Howtek, Inc.
510(k) number
K021949
Product code
LMA
Decision
Substantially Equivalent (SESE)
Decision date
2002-08-12
Date received
2002-06-13
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
N

Applicant Contact#

Contact
JOHN E ROSENSTENGEL
Address
21 Park Ave. Hudson NH US 03051 03051

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LMA#

510(k), Device, Applicant table
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
K022810COBRASCAN CR-1 FILMLESSRadiographic Digital Imaging, Inc.2002-10-11
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