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510(k) K881383

ND1100 BONE DENSITY SCANNER by Nuclear Data, Inc. — Product Code KGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1989
Date Received
April 1, 1988
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)
  • K844835 — ND2100 SPINE SCANNER (April 18, 1985)
  • 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)