1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA
FDA 510(k) K182590 · GE Healthcare
510(k) numberK182590
Submission
- Device name
- 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA
- Applicant
- GE Healthcare
Waukesha, WI, US - Received
- September 20, 2018
- Decision date
- October 19, 2018
- 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.
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| K213689 | Voluson P6, Voluson P8IYN · Traditional | 02/17/2022SE |
| K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertIYN · Traditional | 01/13/2022SE |
| K211488 | Logiq E10IYN · Traditional | 09/10/2021SE |
Questions and answers
When was 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA cleared by the FDA?
1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA (K182590) received a 510(k) decision of Substantially Equivalent on October 19, 2018, 29 days after the submission was received.
What is the product code of K182590?
The FDA product code is MOS – Coil, Magnetic Resonance, Specialty, a Class II (moderate risk) device regulated under 21 CFR 892.1000.