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FDA 510(k)

ulrichINJECT CT Motion (XD 8000)

K-Number: K251295 · 2025-11-07

ApplicantUlrich GmbH & Co. KG
Decision Date2025-11-07
Product CodeIZQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ulrichINJECT CT Motion (XD 8000) is a medical device manufactured by Ulrich GmbH & Co. KG. It received FDA 510(k) clearance on 2025-11-07 under approval number K251295. The device is classified under product code IZQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ulrichINJECT CT Motion (XD 8000)?

ulrichINJECT CT Motion (XD 8000) is a medical device that received FDA 510(k) clearance on 2025-11-07. It is manufactured by Ulrich GmbH & Co. KG. The 510(k) number is K251295.

When was ulrichINJECT CT Motion (XD 8000) approved by the FDA?

ulrichINJECT CT Motion (XD 8000) received FDA 510(k) clearance on 2025-11-07, under approval number K251295.

What company makes ulrichINJECT CT Motion (XD 8000)?

ulrichINJECT CT Motion (XD 8000) is manufactured by Ulrich GmbH & Co. KG.

What is the FDA product code for ulrichINJECT CT Motion (XD 8000)?

The FDA product code for ulrichINJECT CT Motion (XD 8000) is IZQ.

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Related Devices (Code: IZQ)

K151048CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient SetBracco Injeneering K152361OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base SystemLiebel-Flarsheim Company, LLC K171392ulrichINJECT CT motionUlrich GmbH & Co. KG K192872ulrichINJECT CT MotionUlrich GmbH & Co. KG K210541ulrichINJECT CT motionUlrich GmbH & Co. KG K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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