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510(k) K962337

ELITYS OR ELITYS-E by Trophy Radiologie — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1996
Date Received
June 17, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

Other clearances by Trophy Radiologie

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  • K012514 — DIGIPAN / DPI (December 21, 2001)
  • K991455 — ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMI (June 25, 1999)
  • K991912 — MODIFICATION TO DIGIPAN (June 22, 1999)
  • K961826 — DIGIPAN (September 23, 1996)
  • K953936 — ATLANTIS (December 28, 1995)
  • K951074 — STOMAVISION (STV) (September 19, 1995)
  • K950533 — TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY (June 30, 1995)

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