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510(k) K042484

NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER by Nai Technology Products — Product Code LMA

K042484 is an FDA 510(k) premarket notification submitted by Nai Technology Products for the device "NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER". The FDA issued a decision of Substantially Equivalent on October 20, 2004. 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
October 20, 2004
Date Received
September 13, 2004
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

Other clearances for product code LMA

  • K132183 — DICOM VIDEO (October 3, 2013)
  • K130636 — TELERADPRO EDGE; TELERADPRO EDGE HD-CCD (June 7, 2013)
  • K130406 — DIAGNOSTICPRO EDGE (April 29, 2013)
  • K102476 — TELERADPRO (October 7, 2010)
  • K093809 — VIDAR DENTAL FILM DIGITIZER (January 7, 2010)
  • K091288 — MEDI-6000 MEDICAL IMAGE DIGITIZER (August 14, 2009)
  • K063424 — FILM DIGITZER, MODEL 2908 MAMMO PRO (December 21, 2006)
  • 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