Cleared Traditional

1.5T HD T/R Knee Array (10-F34127)

K231085 · Shenzhen RF Tech Co., Ltd. · Radiology
Aug 2023
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K231085 is an FDA 510(k) clearance for the 1.5T HD T/R Knee Array (10-F34127), a Coil, Magnetic Resonance, Specialty (Class II — Special Controls, product code MOS), submitted by Shenzhen RF Tech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 18, 2023, 123 days after receiving the submission on April 17, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K231085 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2023
Decision Date August 18, 2023
Days to Decision 123 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MOS — Coil, Magnetic Resonance, Specialty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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