510(k) K223203

1.5T 24E Posterior Array by Shenzhen RF Tech Co., Ltd. — Product Code LNH

K223203 is an FDA 510(k) premarket notification submitted by Shenzhen RF Tech Co., Ltd. for the device "1.5T 24E Posterior Array". The FDA issued a decision of Substantially Equivalent on March 2, 2023. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Shenzhen RF Tech Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2023
Date Received
October 14, 2022
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