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510(k) K001429

MODIFICATION TO ACCUDEXA BONE DENSITOMETER by Schick Technologies, Inc. — Product Code KGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2000
Date Received
May 5, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Densitometer, Bone
Device Class
Class II
Regulation Number
892.1170
Review Panel
RA
Submission Type

Other clearances by Schick Technologies, Inc.

  • K110768 — COMPUTED DENTAL RADIOGRAPHY (April 20, 2011)
  • K093453 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (November 30, 2009)
  • K072134 — SCHICK COMPUTED ORAL RADIOLOGY SYSTEM (November 2, 2007)
  • K053558 — CEPH, MODEL 4900 (February 17, 2006)
  • K041385 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (June 7, 2004)
  • K031291 — CDR PANX, MODEL 4792 (May 5, 2003)
  • K022953 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (October 2, 2002)
  • K982661 — CDR - PAN MODEL 4700 (December 11, 1998)
  • K981124 — ACCUDEXA BONE DENSITOMETER (June 4, 1998)
  • K971735 — ACCUDEXA BONE DENSITOMETER (December 2, 1997)

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  • K180782 — Aria (April 20, 2018)
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  • K152299 — TBS iNsight (April 29, 2016)