Home / 510(k) Clearances / K233380

510(k) K233380

TRIDENT Mobile Fluoroscopy System by Dornier Medtech America — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2024
Date Received
October 2, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Other clearances by Dornier Medtech America

  • K243820 — Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, I (January 31, 2025)
  • K221903 — Delta III Pro (February 22, 2023)
  • K213252 — Dornier Thulio (July 27, 2022)
  • K220871 — Nautilus (April 18, 2022)
  • K210394 — Electrosurgical accessory (May 19, 2021)
  • K201815 — Dornier MAGELLAN Ureteral Access Sheath (November 20, 2020)
  • K201074 — Delta III Lithotripter (September 3, 2020)
  • K190612 — EQUINOX Balloon Dilatation Catheter (December 6, 2019)
  • K190312 — Dornier Ureteral Stent (November 15, 2019)
  • K191187 — Dornier MINNOW Ureteral Catheter (September 18, 2019)

Other clearances for product code JAA

  • K251650 — Insight Enhanced™ DRF (EN-1002-01) (September 16, 2025)
  • K242488 — Soteria E-View (January 6, 2025)
  • K242948 — Adora DRFi (04550010) (December 23, 2024)
  • K233945 — ProxiDiagnost N90 / Precision CRF (706110, 706400) (January 11, 2024)
  • K232910 — CombiDiagnost R90 (October 19, 2023)
  • K232526 — XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 (September 12, 2023)
  • K220871 — Nautilus (April 18, 2022)
  • K212890 — Nyquist.IQ (December 13, 2021)
  • K212837 — ProxiDiagnost N90 (September 21, 2021)
  • K212145 — DR 800 with DSA, DR 800 (August 31, 2021)