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510(k) K021949

FULCRUM by Howtek, Inc. — Product Code LMA

K021949 is an FDA 510(k) premarket notification submitted by Howtek, Inc. for the device "FULCRUM". The FDA issued a decision of Substantially Equivalent on August 12, 2002. 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
August 12, 2002
Date Received
June 13, 2002
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.

  • K973081 — DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0) (November 5, 1997)
  • K972191 — DIGITIZER DIRECTOR (HSC025-01) (September 8, 1997)
  • K970908 — HOWTEK 960 (May 20, 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