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510(k) K091288

MEDI-6000 MEDICAL IMAGE DIGITIZER by Microtek International, Inc. — Product Code LMA

K091288 is an FDA 510(k) premarket notification submitted by Microtek International, Inc. for the device "MEDI-6000 MEDICAL IMAGE DIGITIZER". The FDA issued a decision of Substantially Equivalent on August 14, 2009. The device falls under product code LMA (Digitizer, Image, Radiological), a Class II device regulated under 21 CFR 892.2030.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2009
Date Received
May 1, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Digitizer, Image, Radiological
Device Class
Class II
Regulation Number
892.2030
Review Panel
RA
Submission Type

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  • K130406 — DIAGNOSTICPRO EDGE (April 29, 2013)
  • K102476 — TELERADPRO (October 7, 2010)
  • K093809 — VIDAR DENTAL FILM DIGITIZER (January 7, 2010)
  • K063424 — FILM DIGITZER, MODEL 2908 MAMMO PRO (December 21, 2006)
  • K042484 — NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER (October 20, 2004)
  • K033637 — MEDICAL IMAGE DIGITIZER, MODEL 2908 (December 17, 2003)
  • K032022 — DIGITAL IMAGER (September 2, 2003)
  • K022810 — COBRASCAN CR-1 FILMLESS (October 11, 2002)

FDA data resources