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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 the device name listed in this FDA 510(k) record. The listed applicant is Ulrich GmbH & Co. KG. It received FDA 510(k) clearance on 2025-11-07 under 510(k) 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. The listed applicant is Ulrich GmbH & Co. KG. The 510(k) number is K251295.

When did ulrichINJECT CT Motion (XD 8000) receive FDA 510(k) clearance?

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

Who is the listed applicant for ulrichINJECT CT Motion (XD 8000)?

The FDA 510(k) record lists Ulrich GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Ulrich GmbH & Co. KG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K233737ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K210541ulrichINJECT CT motionK202227Artus™ cervical plate systemK192872ulrichINJECT CT Motion

View all 11 devices →

Related Devices (Code: IZQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262115VueJect® Ultrasound Enhancing Agent Delivery SystemACIST Medical Systems, Inc.K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KGK252689MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KGK233737ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG

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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