Home / 510(k) Clearances / K001841

510(k) K001841

35/CD CINECONVERTER by Tagarno A/S — Product Code LMA

K001841 is an FDA 510(k) premarket notification submitted by Tagarno A/S for the device "35/CD CINECONVERTER". The FDA issued a decision of Substantially Equivalent on November 15, 2000. 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
November 15, 2000
Date Received
June 19, 2000
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)
  • 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)

FDA data resources