Home / 510(k) Clearances / K991455

510(k) K991455

ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C, by Trophy Radiologie — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1999
Date Received
April 26, 1999
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

  • 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)
  • K991912 — MODIFICATION TO DIGIPAN (June 22, 1999)
  • K961826 — DIGIPAN (September 23, 1996)
  • K962337 — ELITYS OR ELITYS-E (July 25, 1996)
  • K953936 — ATLANTIS (December 28, 1995)
  • K951074 — STOMAVISION (STV) (September 19, 1995)
  • K950533 — TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY (June 30, 1995)

Other clearances for product code EHD

  • K252110 — Dental X-RAY Unit (AJX200) (March 12, 2026)
  • K254018 — Portable Dental X-ray Device (GT-1) (February 19, 2026)
  • K252909 — Diagnostic X-Ray Equipment Model POCT22 (February 3, 2026)
  • K251438 — Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) (September 4, 2025)
  • K242185 — Rextar Pro (December 4, 2024)
  • K242591 — XERO-alpha (November 1, 2024)
  • K241963 — WERAY (July 30, 2024)
  • K241305 — LifeRay Intraoral Handheld X-ray System (July 5, 2024)
  • K240759 — REMEX-GR100 (May 13, 2024)
  • K233914 — XVbeam2000 (February 8, 2024)