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

FDA 510(k)

MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE

K-Number: K033881 · 2004-03-02

ApplicantMedrad, Inc.
Decision Date2004-03-02
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 2004-03-02 under 510(k) number K033881. 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 STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE?

MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE is a medical device that received FDA 510(k) clearance on 2004-03-02. The listed applicant is Medrad, Inc.. The 510(k) number is K033881.

When did MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE receive FDA 510(k) clearance?

MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE received FDA 510(k) clearance on 2004-03-02, under 510(k) number K033881.

Who is the listed applicant for MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE?

The FDA 510(k) record lists Medrad, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE?

The FDA product code for MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE is DXT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medrad, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130381ANGIOJET ULTRA POWER PULSE KITK130637JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEMK122916JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEMK113363ANGIOJET SOLENT DISTA THROMBECTOMY SETK113133MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGEK113428ANGIOJET ULTRA DVX THROMBECTOMY SET

View all 104 devices →

Related Devices (Code: DXT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable SyrFortis Biosolutions Company LimitedK252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)Acist Medical Systems, Inc.K252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer CableAcist Medical Systems, Inc.K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd.K251788Extension tubeZhuhai DR Medical Instruments Co., Ltd.K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)Bayer Medical Care, 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.

↑