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510(k) K982785

FILM DIGITIZER MODEL 2905 by Array Corp. — Product Code LMA

K982785 is an FDA 510(k) premarket notification submitted by Array Corp. for the device "FILM DIGITIZER MODEL 2905". The FDA issued a decision of Substantially Equivalent on October 15, 1998. The device falls under product code LMA (Digitizer, Image, Radiological), a Class II device regulated under 21 CFR 892.2030. Array Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1998
Date Received
August 7, 1998
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 Array Corp.

  • K063424 — FILM DIGITZER, MODEL 2908 MAMMO PRO (December 21, 2006)
  • K033637 — MEDICAL IMAGE DIGITIZER, MODEL 2908 (December 17, 2003)

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