Home / 510(k) Clearances / K953936

510(k) K953936

ATLANTIS by Trophy Radiologie — Product Code EAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1995
Date Received
August 21, 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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  • K951074 — STOMAVISION (STV) (September 19, 1995)
  • K950533 — TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY (June 30, 1995)

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  • K954565 — EXPLOR-X (AZTEH) HF (October 27, 1995)
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