510(k) K241242

SIGNA MAGNUS by Ge Medical Systems, LLC — Product Code LNH

K241242 is an FDA 510(k) premarket notification submitted by Ge Medical Systems, LLC for the device "SIGNA MAGNUS". The FDA issued a decision of Substantially Equivalent on October 17, 2024. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Ge Medical Systems, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2024
Date Received
May 3, 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