ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
FDA 510(k) K233737 · Ulrich GmbH & Co. KG
510(k) numberK233737
Submission
- Device name
- ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
- Applicant
- Ulrich GmbH & Co. KG
Ulm, DE - Received
- November 22, 2023
- Decision date
- April 19, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IZQ – Injector, Contrast Medium, Automatic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Specialty
- Cardiovascular
Other 510(k)s with product code IZQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262115 | VueJect® Ultrasound Enhancing Agent Delivery SystemIZQ · Traditional | ACIST Medical Systems, Inc. | 08/03/2026SE |
| K252281 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional | Ulrich GmbH & Co. KG | 11/18/2025SE |
| K251295 | ulrichINJECT CT Motion (XD 8000)IZQ · Traditional | Ulrich GmbH & Co. KG | 11/07/2025SE |
| K252689 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient…IZQ · Special | Imaxeon Pty, Ltd. | 09/24/2025SE |
| K241849 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient…IZQ · Traditional | Imaxeon Pty, Ltd. | 11/05/2024SE |
| K241850 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional | Ulrich GmbH & Co. KG | 08/26/2024SE |
| K210541 | ulrichINJECT CT motionIZQ · Traditional | Ulrich GmbH & Co. KG | 08/06/2021SE |
| K192872 | ulrichINJECT CT MotionIZQ · Traditional | Ulrich GmbH & Co. KG | 07/02/2020SE |
| K171392 | ulrichINJECT CT motionIZQ · Traditional | Ulrich GmbH & Co. KG | 11/09/2017SE |
| K151048 | CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP…IZQ · Traditional | Bracco Injeneering | 01/22/2016SE |
More from Bracco Injeneering
| 510(k) | Device | Decision |
|---|---|---|
| K252281 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional | 11/18/2025SE |
| K251295 | ulrichINJECT CT Motion (XD 8000)IZQ · Traditional | 11/07/2025SE |
| K241850 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional | 08/26/2024SE |
| K210541 | ulrichINJECT CT motionIZQ · Traditional | 08/06/2021SE |
| K202227 | Artus cervical plate systemKWQ · Traditional | 09/14/2020SE |
| K192872 | ulrichINJECT CT MotionIZQ · Traditional | 07/02/2020SE |
| K192117 | Small VBRMQP · Traditional | 11/01/2019SE |
| K171392 | ulrichINJECT CT motionIZQ · Traditional | 11/09/2017SE |
| K161032 | neon3 universal OCT spinal stabilizationNKG · Traditional | 12/22/2016SE |
| K161723 | ulrich Transfer SetPQH · Traditional | 12/21/2016SE |
Questions and answers
When was ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) cleared by the FDA?
ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) (K233737) received a 510(k) decision of Substantially Equivalent on April 19, 2024, 149 days after the submission was received.
What is the product code of K233737?
The FDA product code is IZQ – Injector, Contrast Medium, Automatic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.