Teslacon NMR Imaging System

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Teslacon(Tm) Nmr Imaging System

Generic Name

System, nuclear magnetic resonance imaging

PMA Number

P830051 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

APPR Approved

PMA Supplement

S009

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  FDA 510(k) K812410 Active Cleared 2 Oct 1981

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  FDA 510(k) K800892 Active Cleared 14 May 1980

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• What is the primary clinical use of the Teslacon NMR Imaging System, and how does it help in medical diagnostics?

  The Teslacon NMR Imaging System is designed to generate detailed cross-sectional images of the human body using strong magnetic fields and radio waves. It aids in diagnosing and monitoring medical conditions such as tumors, organ abnormalities, and musculoskeletal disorders by providing high-resolution visualizations of internal structures, which assist radiologists in accurate assessments.

• Is the Teslacon NMR Imaging System intended for single-use or reusable applications in clinical settings?

  The device data does not explicitly specify whether the Teslacon NMR Imaging System is single-use or reusable. However, as a Class II medical device under FDA regulations, it is subject to performance standards and quality system requirements, implying it is likely designed for repeated use in clinical radiology departments with appropriate maintenance protocols.

• What regulatory pathway was followed for the approval of the Teslacon NMR Imaging System, and what does this indicate about its oversight?

  The Teslacon NMR Imaging System received FDA Premarket Approval (PMA) under PMA number P830051, indicating it underwent a rigorous review process to ensure safety and effectiveness. This approval pathway is typically reserved for higher-risk devices, and the system is classified as Class II, meaning it is subject to performance standards and ongoing regulatory compliance to maintain its intended use in radiology departments.

• How is the Teslacon NMR Imaging System categorized in terms of medical specialty, and where would it typically be deployed?

  The system is categorized under the medical specialty of Radiology, with an advisory committee designation of RA (Radiology Advisory Committee). It is intended for use in radiology departments within clinical settings, where it supports diagnostic imaging for evaluating internal body structures.