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510(k) K210541

ulrichINJECT CT motion by Ulrich GmbH & Co. KG — Product Code IZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2021
Date Received
February 24, 2021
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

Other clearances by Ulrich GmbH & Co. KG

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  • K251295 — ulrichINJECT CT Motion (XD 8000) (November 7, 2025)
  • 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)
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  • K192117 — Small VBR™ (November 1, 2019)
  • K171392 — ulrichINJECT CT motion (November 9, 2017)
  • K161032 — neon3™ universal OCT spinal stabilization (December 22, 2016)
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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)
  • 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)
  • K152361 — OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspens (January 14, 2016)