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510(k) K953936

ATLANTIS by Trophy Radiologie — Product Code EAP

K953936 is an FDA 510(k) premarket notification submitted by Trophy Radiologie for the device "ATLANTIS". The FDA issued a decision of Substantially Equivalent on December 28, 1995. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. Trophy Radiologie has at least 10 other 510(k) clearances on record.

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

Other clearances by Trophy Radiologie

  • K033690 — TROPHYPAN AND TROPHYPAN C (February 20, 2004)
  • K033419 — STV PRO 2 (February 2, 2004)
  • K023346 — TROPHYPAN (January 3, 2003)
  • 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)
  • K962337 — ELITYS OR ELITYS-E (July 25, 1996)
  • K951074 — STOMAVISION (STV) (September 19, 1995)
  • K950533 — TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY (June 30, 1995)

Other clearances for product code EAP

  • K113360 — MEDICAL IMAGE PROCESSING UNIT (February 7, 2012)
  • K102573 — PROVU (TM) DENTAL X-RAY SYSTEM (June 30, 2011)
  • K093453 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (November 30, 2009)
  • K080738 — DENTRON SENSOR (May 13, 2008)
  • K052422 — THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) (September 27, 2005)
  • 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)
  • K954565 — EXPLOR-X (AZTEH) HF (October 27, 1995)
  • K951734 — LUMIX 70B (July 20, 1995)

FDA data resources