MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
FDA 510(k) K143538 · Bayer Medical Care, Inc.
510(k) numberK143538
Submission
- Device name
- MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
- Applicant
- Bayer Medical Care, Inc.
Indianaola, PA, US - Received
- December 15, 2014
- Decision date
- August 14, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXT – Injector And Syringe, Angiographic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Specialty
- Cardiovascular
Other 510(k)s with product code DXT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252652 | Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes…DXT · Traditional | Fortis Biosolutions Company Limited | 05/14/2026SE |
| K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module…DXT · Traditional | Acist Medical Systems, Inc. | 05/13/2026SE |
| K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use…DXT · Traditional | Acist Medical Systems, Inc. | 05/13/2026SE |
| K253048 | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeDXT · Traditional | Shenzhen Maiwei Biotech Co., Ltd. | 04/16/2026SE |
| K251788 | Extension tubeDXT · Traditional | Zhuhai DR Medical Instruments Co., Ltd. | 03/05/2026SE |
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2…DXT · Traditional | Bayer Medical Care, Inc. | 02/13/2026SE |
| K244038 | High Pressure TubingDXT · Traditional | Shandong Int Medical Instruments Co., Ltd. | 09/05/2025SE |
| K242143 | Angiography InjectorDXT · Traditional | Shandong Int Medical Instruments Co., Ltd. | 12/23/2024SE |
| K242212 | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)DXT · Traditional | Nemoto Kyorindo Co., Ltd. | 08/27/2024SE |
| K241109 | Single-use Sterile High-pressure Angiographic Syringes and AccessoriesDXT · Traditional | Shenzhen Boon Medical Supply Co., Ltd. | 08/22/2024SE |
More from Shenzhen Boon Medical Supply Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253688 | MEDRAD® Imaging Bulk Package Transfer SpikePQH · Traditional | 06/12/2026SE |
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2…DXT · Traditional | 02/13/2026SE |
| K250893 | Ball Joint Guide Array (66295)HAW · Traditional | 09/04/2025SE |
| K200280 | MEDRAD Imaging Bulk Package Transfer SpikePQH · Traditional | 07/30/2020SE |
| K192370 | MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationDXT · Traditional | 12/13/2019SE |
| K193028 | MEDRAD Mark 7 Arterion Injection SystemDXT · Special | 12/05/2019SE |
| K182276 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe KitDXT · Special | 11/01/2018SE |
| K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…DXT · Special | 11/01/2018SE |
| K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…DXT · Traditional | 08/17/2018SE |
Questions and answers
When was MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit cleared by the FDA?
MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit (K143538) received a 510(k) decision of Substantially Equivalent on August 14, 2015, 242 days after the submission was received.
What is the product code of K143538?
The FDA product code is DXT – Injector And Syringe, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.