510(k) K251295
K251295 is an FDA 510(k) premarket notification submitted by Ulrich GmbH & Co. KG for the device "ulrichINJECT CT Motion (XD 8000)". The FDA issued a decision of Substantially Equivalent on November 7, 2025. The device falls under product code IZQ (Injector, Contrast Medium, Automatic), a Class II device regulated under 21 CFR 870.1650. Ulrich GmbH & Co. KG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 2025
- Date Received
- April 25, 2025
- 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