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510(k) K173395

MECALL CLISIS SYSTEMS, Discovery RF180 by General Medical Merate S.P.A — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2018
Date Received
October 30, 2017
Clearance Type
Special
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 General Medical Merate S.P.A

  • K213081 — CLISIS SYSTEMS, Discovery RF180 (October 26, 2021)
  • K140380 — OPERA SWING (September 26, 2014)
  • K082243 — PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS (November 7, 2008)
  • K041605 — PRECISION RXI ANALOG X-RAY SYSTEM (June 30, 2004)
  • K881386 — X-RAY GENERATING SYSTEM TF 1000 (July 8, 1988)
  • K827993 — MTH C/A MOBILE C ARM (September 13, 1982)

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