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LMA — Digitizer, Image, Radiological Class II

FDA Device Classification

FDA product code LMA covers "Digitizer, Image, Radiological", a Class II medical device regulated under 21 CFR 892.2030. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LMA
Device Class
Class II
Regulation Number
892.2030
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K132183bar code computerDICOM VIDEOOctober 3, 2013
K130636vidar systemsTELERADPRO EDGE; TELERADPRO EDGE HD-CCDJune 7, 2013
K130406vidar systemsDIAGNOSTICPRO EDGEApril 29, 2013
K102476vidar systemsTELERADPROOctober 7, 2010
K093809vidar systemsVIDAR DENTAL FILM DIGITIZERJanuary 7, 2010
K091288microtek internationalMEDI-6000 MEDICAL IMAGE DIGITIZERAugust 14, 2009
K063424arrayFILM DIGITZER, MODEL 2908 MAMMO PRODecember 21, 2006
K042484nai technology productsNAI TECH PRODUCTS MEDICAL DIGITAL RECORDEROctober 20, 2004
K033637arrayMEDICAL IMAGE DIGITIZER, MODEL 2908December 17, 2003
K032022pyramid medicalDIGITAL IMAGERSeptember 2, 2003
K022810radiographic digital imagingCOBRASCAN CR-1 FILMLESSOctober 11, 2002
K021949howtekFULCRUMAugust 12, 2002
K020243eradlinkLASERPRO 16March 5, 2002
K013631efilm medicalEFILM VIDEONovember 20, 2001
K013395ferraniaLIFEJET VIDEO LINKOctober 30, 2001
K011049vidar systemsEXPRESSSUITEOctober 1, 2001
K001841tagarno35/CD CINECONVERTERNovember 15, 2000
K000411steinbeis-transferzentrum medizinische informatikCHILI VIDEO, CHILI VIDEOPROApril 14, 2000
K992467dba systemsIMAGCLEAR MAMMOGRAPHY REVIEW SYSTEMFebruary 10, 2000
K993598vidar systemsMAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205January 20, 2000

FDA data resources