Cleared Traditional

ulrichINJECT CT Motion (XD 8000)

K251295 · Ulrich GmbH & Co. KG · General Hospital
Nov 2025
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K251295 is an FDA 510(k) clearance for the ulrichINJECT CT Motion (XD 8000), a Injector, Contrast Medium, Automatic (Class II — Special Controls, product code IZQ), submitted by Ulrich GmbH & Co. KG (Ulm, DE). The FDA issued a Cleared decision on November 7, 2025, 196 days after receiving the submission on April 25, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K251295 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2025
Decision Date November 07, 2025
Days to Decision 196 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code IZQ — Injector, Contrast Medium, Automatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1650

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