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510(k) K130636

TELERADPRO EDGE; TELERADPRO EDGE HD-CCD by Vidar Systems Corp. — Product Code LMA

K130636 is an FDA 510(k) premarket notification submitted by Vidar Systems Corp. for the device "TELERADPRO EDGE; TELERADPRO EDGE HD-CCD". The FDA issued a decision of Substantially Equivalent on June 7, 2013. The device falls under product code LMA (Digitizer, Image, Radiological), a Class II device regulated under 21 CFR 892.2030. Vidar Systems Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2013
Date Received
March 11, 2013
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.

  • 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)
  • K993597 — PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617 (December 15, 1999)

Other clearances for product code LMA

  • K132183 — DICOM VIDEO (October 3, 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)
  • K022810 — COBRASCAN CR-1 FILMLESS (October 11, 2002)

FDA data resources