Cleared Traditional

K231085 - 1.5T HD T/R Knee Array (10-F34127)

K231085 is an FDA 510(k) clearance for 1.5T HD T/R Knee Array (10-F34127), manufactured by Shenzhen RF Tech Co., Ltd.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 123-day FDA review.

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

K231085 is an FDA 510(k) clearance for the 1.5T HD T/R Knee Array (10-F34127). Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Shenzhen RF Tech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 18, 2023 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen RF Tech Co., Ltd. devices

FDA 510(k) Submission Details - K231085

510(k) Number K231085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 107d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOS Device Classification - Class 2, Special Controls

Product Code MOS Coil, Magnetic Resonance, Specialty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MOS Coil, Magnetic Resonance, Specialty

All 312
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K231085.
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Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
K232021 · Philips Healthcare (Suzhou) Co., Ltd. · Sep 2023
IGAR System (1001.A)
K223484 · Insight Medbotics, Inc. · Jul 2023
XENOVIEW 3.0T Chest Coil
K231647 · Polarean, Inc. · Jun 2023
8ch T/R Knee Coil
K223225 · Shenzhen RF Tech Co., Ltd. · Feb 2023