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510(k) K950533

TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY by Trophy Radiologie — Product Code EAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1995
Date Received
February 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Intraoral
Device Class
Class II
Regulation Number
872.1810
Review Panel
RA
Submission Type

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  • K962337 — ELITYS OR ELITYS-E (July 25, 1996)
  • K953936 — ATLANTIS (December 28, 1995)
  • K951074 — STOMAVISION (STV) (September 19, 1995)

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  • K041385 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (June 7, 2004)
  • K960819 — HELIODENT DS (March 29, 1996)
  • K960028 — ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM (March 1, 1996)
  • K953936 — ATLANTIS (December 28, 1995)
  • K954565 — EXPLOR-X (AZTEH) HF (October 27, 1995)