Home / 510(k) Clearances / K032022

510(k) K032022

DIGITAL IMAGER by Pyramid Medical, Inc. — Product Code LMA

K032022 is an FDA 510(k) premarket notification submitted by Pyramid Medical, Inc. for the device "DIGITAL IMAGER". The FDA issued a decision of Substantially Equivalent on September 2, 2003. The device falls under product code LMA (Digitizer, Image, Radiological), a Class II device regulated under 21 CFR 892.2030.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2003
Date Received
June 30, 2003
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 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)
  • K022810 — COBRASCAN CR-1 FILMLESS (October 11, 2002)

FDA data resources