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)

ACHIEVA 1.5T & INERA 1.5T FAMILY

K-Number: K052013 · 2005-08-02

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2005-08-02
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACHIEVA 1.5T & INERA 1.5T FAMILY is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2005-08-02 under 510(k) number K052013. 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 ACHIEVA 1.5T & INERA 1.5T FAMILY?

ACHIEVA 1.5T & INERA 1.5T FAMILY is a medical device that received FDA 510(k) clearance on 2005-08-02. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K052013.

When did ACHIEVA 1.5T & INERA 1.5T FAMILY receive FDA 510(k) clearance?

ACHIEVA 1.5T & INERA 1.5T FAMILY received FDA 510(k) clearance on 2005-08-02, under 510(k) number K052013.

Who is the listed applicant for ACHIEVA 1.5T & INERA 1.5T FAMILY?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACHIEVA 1.5T & INERA 1.5T FAMILY?

The FDA product code for ACHIEVA 1.5T & INERA 1.5T FAMILY 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 Philips Medical Systems Nederland B.V. 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.

K254205Zenition 30K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TK262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TK260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)K253614EchoNavigator R5.0K260169AV Cardiac CT

View all 97 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.

↑