Gem Option for 1.5 MRI Systems
FDA 510(k) K103335 · GE Healthcare
510(k) numberK103335
Submission
- Device name
- Gem Option for 1.5 MRI Systems
- Applicant
- GE Healthcare
Aurora, OH, US - Received
- November 15, 2010
- Decision date
- March 7, 2011
- 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 |
|---|---|---|
| K253639 | ViewLLZ · Traditional | 01/08/2026SE |
| K242925 | MR Contour DLQKB · Traditional | 04/01/2025SE |
| K241300 | ViewPoint 6LLZ · Traditional | 07/02/2024SE |
| K232346 | Digital Expert Access with Remote ScanningLNH · Traditional | 10/27/2023SE |
| K223212 | Precision DLKPS · Traditional | 04/27/2023SE |
| K221680 | Xeleris V Processing and Review SystemLLZ · Traditional | 03/01/2023SE |
| K221932 | Omni LegendKPS · Traditional | 09/02/2022SE |
| 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 Gem Option for 1.5 MRI Systems cleared by the FDA?
Gem Option for 1.5 MRI Systems (K103335) received a 510(k) decision of Substantially Equivalent on March 7, 2011, 112 days after the submission was received.
What is the product code of K103335?
The FDA product code is MOS – Coil, Magnetic Resonance, Specialty, a Class II (moderate risk) device regulated under 21 CFR 892.1000.