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)

ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000

K-Number: K933645 · 1993-11-12

ApplicantHitachi Medical Systems America, Inc.
Decision Date1993-11-12
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 1993-11-12 under 510(k) number K933645. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000?

ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000 is a medical device that received FDA 510(k) clearance on 1993-11-12. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K933645.

When did ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000 receive FDA 510(k) clearance?

ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000 received FDA 510(k) clearance on 1993-11-12, under 510(k) number K933645.

Who is the listed applicant for ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000?

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

What is the FDA product code for ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000?

The FDA product code for ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000 is LNH.

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 Hitachi Medical Systems America, 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.

K163528HITACHI Supria Whole-body X-ray CT System Phase 3K162079TRILLIUM Oval Head Coil 32K161748SUPRIA w/guideShot OptionK160152Trillium Oval V 5.1 MRI SystemK153547ECHELON Oval V 5.1 MRI SystemK123509SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM

View all 95 devices →

Related Devices (Code: LNH)

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.

K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd.K261283APERTO Lucent MRI SystemFujifilm CorporationK260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd.K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc.K254250MagicScan-1.5, GreenMR Serenity 1.5TXingaoyi Medical Equipment Co.,LtdK253808AIR Recon DLGE Medical Systems

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.

↑