1.5T HD T/R Knee Array (10-F34127)
FDA 510(k) K231085 · Shenzhen RF Tech Co., Ltd.
510(k) numberK231085
Submission
- Device name
- 1.5T HD T/R Knee Array (10-F34127)
- Applicant
- Shenzhen RF Tech Co., Ltd.
Shenzhen, CN - Received
- April 17, 2023
- Decision date
- August 18, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MOS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262330 | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil…MOS · Special | Philips Medical Systems Nederland B.V. | 07/30/2026SE |
| K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes…MOS · Special | Philips Medical Systems Nederland B.V. | 07/24/2026SE |
| K260947 | 0.55T 12Ch Breast CoilMOS · Special | Neocoil, LLC | 04/23/2026SE |
| K252587 | HD 8Ch Wrist ArrayMOS · Traditional | Shenzhen RF Tech Co., Ltd. | 04/14/2026SE |
| K252876 | GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive…MOS · Traditional | Shenzhen RF Tech Co., Ltd. | 04/01/2026SE |
| K260519 | Smart Fit TorsoCardiac 1.5TMOS · Special | Philips Healthcare (Suzhou) Co., Ltd. | 03/20/2026SE |
| K252179 | GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive…MOS · Traditional | Shenzhen RF Tech Co., Ltd. | 02/10/2026SE |
| K253738 | 3.0T Air 32CH HnaMOS · Abbreviated | Ge Healthcare Coils (Usa Instruments, Inc.) | 01/23/2026SE |
| K254190 | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0TMOS · Special | Philips Medical Systems Nederland B.V. | 01/14/2026SE |
| K253182 | InkSpace Imaging Small Body Array (SBA12PH30x)MOS · Special | Inkspace Imaging, Inc. | 10/20/2025SE |
More from Inkspace Imaging, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252587 | HD 8Ch Wrist ArrayMOS · Traditional | 04/14/2026SE |
| K252876 | GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive…MOS · Traditional | 04/01/2026SE |
| K252179 | GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive…MOS · Traditional | 02/10/2026SE |
| K223203 | 1.5T 24E Posterior ArrayLNH · Traditional | 03/02/2023SE |
| K223225 | 8ch T/R Knee CoilMOS · Traditional | 02/14/2023SE |
| K223239 | 8ch Wrist CoilMOS · Traditional | 12/08/2022SE |
| K200836 | 8ch Flex SuiteMOS · Traditional | 07/22/2020SE |
| K172222 | 8ch Flex SuiteMOS · Traditional | 12/08/2017SE |
| K160932 | 8ch Foot Ankle CoilMOS · Traditional | 08/01/2016SE |
| K160935 | 8ch Foot Ankle CoilMOS · Traditional | 07/28/2016SE |
Questions and answers
When was 1.5T HD T/R Knee Array (10-F34127) cleared by the FDA?
1.5T HD T/R Knee Array (10-F34127) (K231085) received a 510(k) decision of Substantially Equivalent on August 18, 2023, 123 days after the submission was received.
What is the product code of K231085?
The FDA product code is MOS – Coil, Magnetic Resonance, Specialty, a Class II (moderate risk) device regulated under 21 CFR 892.1000.