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510(k) K041605

PRECISION RXI ANALOG X-RAY SYSTEM by General Medical Merate S.P.A — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2004
Date Received
June 15, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Interventional fluoroscopy

Other clearances by General Medical Merate S.P.A

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  • K173395 — MECALL CLISIS SYSTEMS, Discovery RF180 (May 21, 2018)
  • K140380 — OPERA SWING (September 26, 2014)
  • K082243 — PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS (November 7, 2008)
  • K881386 — X-RAY GENERATING SYSTEM TF 1000 (July 8, 1988)
  • K827993 — MTH C/A MOBILE C ARM (September 13, 1982)

Other clearances for product code OWB

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  • K251602 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (October 10, 2025)