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510(k) K970908

HOWTEK 960 by Howtek, Inc. — Product Code LMA

K970908 is an FDA 510(k) premarket notification submitted by Howtek, Inc. for the device "HOWTEK 960". The FDA issued a decision of Substantially Equivalent on May 20, 1997. The device falls under product code LMA (Digitizer, Image, Radiological), a Class II device regulated under 21 CFR 892.2030. Howtek, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1997
Date Received
March 11, 1997
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 Howtek, Inc.

  • K021949 — FULCRUM (August 12, 2002)
  • K973081 — DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0) (November 5, 1997)
  • K972191 — DIGITIZER DIRECTOR (HSC025-01) (September 8, 1997)
  • K953117 — SCANMASTER DX (January 18, 1996)

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