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Supernova C5 MRI System

by Liaoning Kampo Medical System Co., Ltd.

510(k) K131737

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK131737 Date23 Oct 2014ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Supernova C5 MRI System is a nuclear magnetic resonance imaging system. It functions as a diagnostic imaging device that produces transverse, sagittal, coronal, and oblique cross-sectional images of the internal structures of the body.

This device is classified as a Class II medical device under FDA regulation number 892.1000. It has received FDA 510(k) clearance under reference number K131737.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Supernova C5 MRI System?

    The Supernova C5 is a diagnostic imaging device that utilizes nuclear magnetic resonance technology. It is designed to generate transverse, sagittal, coronal, and oblique cross-sectional images of internal body structures for clinical diagnostic purposes.

  • What is the regulatory status of this device?

    The Supernova C5 MRI System is classified as a Class II medical device under FDA regulation number 892.1000. It has received FDA 510(k) clearance under reference number K131737.

  • Who is the manufacturer of the Supernova C5 MRI System?

    The device is manufactured by Liaoning Kampo Medical System Co., Ltd., located in the Benxi Economic Development Area, Liaoning, China.