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510(k) K844835

ND2100 SPINE SCANNER by Nuclear Data, Inc. — Product Code KGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1985
Date Received
December 12, 1984
Clearance Type
Traditional
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 Nuclear Data, Inc.

  • K891466 — ACCUSPEC THYROID UPTAKE SYSTEM (June 6, 1989)
  • K881383 — ND1100 BONE DENSITY SCANNER (May 22, 1989)
  • K844766 — ND1100 BONE DENSITY SCANNER (April 16, 1985)
  • K843349 — ND3100 VIDEO IMAGER (December 17, 1984)
  • K841440 — ND62T THYROID UPTAKE SYSTEM (June 5, 1984)
  • K841352 — ND1200 RIA COUNTER (May 2, 1984)

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  • K220402 — VirtuOst (May 19, 2023)
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  • K213760 — ABMD Software (July 29, 2022)
  • K191112 — GEHC DXA Bone Densitometers with enCORE version 18 (September 19, 2019)
  • K180782 — Aria (April 20, 2018)
  • K161682 — GE Lunar DXA Bone Densitometers with enCORE version 17 (December 2, 2016)
  • K152299 — TBS iNsight (April 29, 2016)