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510(k) K242573

NIDO Baby Magnetic Resonance Imaging System by Jiangsu Lici Medical Device Co., Ltd. — Product Code LNH

K242573 is an FDA 510(k) premarket notification submitted by Jiangsu Lici Medical Device Co., Ltd. for the device "NIDO Baby Magnetic Resonance Imaging System". The FDA issued a decision of Substantially Equivalent on December 23, 2024. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2024
Date Received
August 29, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

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FDA data resources