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NIDO Baby Magnetic Resonance Imaging System

by Jiangsu Lici Medical Device Co., Ltd.

510(k) K242573

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 NumberK242573 Date23 Dec 2024ClearedStatusActive

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  • Withdrawn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, 21 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 NIDO Baby Magnetic Resonance Imaging System is a magnetic resonance imaging device used for producing axial, sagittal, coronal and oblique images that display the internal structure of neonatal or infant head. It is classified as a System, Nuclear Magnetic Resonance Imaging under FDA device classification.

The device received FDA 510(k) clearance under K242573 on 2024-12-23 and is manufactured by Jiangsu Lici Medical Device Co., Ltd. It is authorized for use in radiology and is substantially equivalent to a predicate device.

Questions

AI-generated answers, 21 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 NIDO Baby Magnetic Resonance Imaging System used for?

    The NIDO Baby Magnetic Resonance Imaging System is used for producing axial, sagittal, coronal and oblique images that display the internal structure of neonatal or infant head. It is a magnetic resonance imaging device designed specifically for neonatal or infant head imaging in radiology settings.

  • Who manufactures the NIDO Baby MRI System and where are they located?

    The NIDO Baby Magnetic Resonance Imaging System is manufactured by Jiangsu Lici Medical Device Co., Ltd., located at 277 Yuzhou S. Rd., Haizhou District, Jiangsu, China. The manufacturer's contact is Bing Keong Li.

  • What regulatory authorization does the NIDO Baby MRI System have and when was it cleared?

    The NIDO Baby Magnetic Resonance Imaging System received FDA 510(k) clearance under K242573 on 2024-12-23. It was found substantially equivalent to a predicate device and classified as a System, Nuclear Magnetic Resonance Imaging under FDA device classification.