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510(k) K063090

MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY by Medrad, Inc. — Product Code IZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2007
Date Received
October 10, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Contrast Medium, Automatic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

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  • K122916 — JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETST (October 19, 2012)
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  • K113133 — MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 AR (December 15, 2011)
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  • K111182 — ANGIOJET SOLENT OMNI THROMBECTOMY SET (May 24, 2011)
  • K100798 — MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRAT (June 23, 2010)

Other clearances for product code IZQ

  • K252281 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheas (November 18, 2025)
  • K251295 — ulrichINJECT CT Motion (XD 8000) (November 7, 2025)
  • K252689 — MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Pa (September 24, 2025)
  • K241849 — MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Pa (November 5, 2024)
  • K241850 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheas (August 26, 2024)
  • K233737 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheas (April 19, 2024)
  • K210541 — ulrichINJECT CT motion (August 6, 2021)
  • K192872 — ulrichINJECT CT Motion (July 2, 2020)
  • K171392 — ulrichINJECT CT motion (November 9, 2017)
  • K151048 — CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP (January 22, 2016)