Medical Device Manufacturer · CN , Shenzhen

Shenzhen RF Tech Co., Ltd. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2015

Total

Cleared

Denied

FDA 510(k) Regulatory Record - Shenzhen RF Tech Co., Ltd. Radiology ✕

12 devices

1-12 of 12

GEM Flex Coil 16-L Array, 3.0T Receive Only

K252876 · MOS

Radiology · 203d

Cleared Feb 10, 2026

GEM Flex Coil 16-L Array, 1.5T Receive Only

K252179 · MOS

Radiology · 214d

Cleared Aug 18, 2023

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

K231085 · MOS

Radiology · 123d

Cleared Mar 02, 2023

1.5T 24E Posterior Array

Regulatory Intelligence

Regulatory consultants 510(k) submission support ecosystem

Bonnier QM Consulting Center

Bonnier Quality Supervision Consulting (Jm) Center

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 06, 2026

Shenzhen RF Tech Co., Ltd. - FDA 510(k) Cleared Devices

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