Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit

K-Number: K182276 · 2018-11-01

ApplicantBayer Medical Care, Inc.
Decision Date2018-11-01
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit is a medical device manufactured by Bayer Medical Care, Inc.. It received FDA 510(k) clearance on 2018-11-01 under approval number K182276. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit?

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit is a medical device that received FDA 510(k) clearance on 2018-11-01. It is manufactured by Bayer Medical Care, Inc.. The 510(k) number is K182276.

When was MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit approved by the FDA?

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit received FDA 510(k) clearance on 2018-11-01, under approval number K182276.

What company makes MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit?

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit is manufactured by Bayer Medical Care, Inc..

What is the FDA product code for MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit?

The FDA product code for MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit is DXT.

Related Clinical Trials

NCT07224464 The Sarah Nanotechnology System for Treatment of Advanced Metastatic Solid Tumors Using Hyperthermia. RECRUITING NCT07585812 Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia COMPLETED NCT07581249 This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth COMPLETED NCT06411054 The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVA RECRUITING NCT04766684 Clubfoot Tenotomy Trial COMPLETED NCT07557160 Dentapen® vs. Traditional Syringes for Child Dental Anxiety NOT_YET_RECRUITING

Other Devices by Bayer Medical Care, Inc.

K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT K173773MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT K192370MEDRAD Stellant FLEX CT Injection System with Certegra Workstation K193028MEDRAD Mark 7 Arterion Injection System K200280MEDRAD Imaging Bulk Package Transfer Spike K250893Ball Joint Guide Array (66295)

View all 8 devices →

Related Devices (Code: DXT)

K152906Disposable High Pressure Injector SyringeWuxi Yushou Medical Appliances Co., Ltd. K160190Sunmed Control SyringesSunny Medical Device (Shenzhen) Co., Ltd. K161471MR Syringe Dual Pack for Solaris InjectorsCoeur, Inc. K161505DyeVert NG Contrast Modulation SystemOsprey Medical, Inc. K160107DiamondTOUCH Inflation Device and Fluid Dispensing SyringeMerit Medical Systems, Inc. K152978DeRoyal Angiography KitsDeroyal Industries, Inc.

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.

↑