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510(k) K993597

PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617 by Vidar Systems Corp. — Product Code LMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1999
Date Received
October 25, 1999
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 by Vidar Systems Corp.

  • 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)
  • K071193 — VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS (May 30, 2007)
  • K070563 — VIDAR VISION 2000 (March 16, 2007)
  • K024171 — VIDAR BONE TRACK SYSTEM SOFTWARE (March 4, 2003)
  • K011049 — EXPRESSSUITE (October 1, 2001)
  • K993598 — MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 (January 20, 2000)
  • K993599 — DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13 (January 18, 2000)

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)