Atama System
FDA 510(k) K110411 · Monteris Medical, Inc.
510(k) numberK110411
Submission
- Device name
- Atama System
- Applicant
- Monteris Medical, Inc.
Winnipeg, Mb, CA - Received
- February 14, 2011
- Decision date
- April 8, 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 |
|---|---|---|
| K262315 | NeuroBlate SystemONO · Traditional | 09/03/2026SE |
| K260976 | NeuroBlate SystemONO · Special | 04/23/2026SE |
| K240877 | Monteris Medical NeuroBlate SystemONO · Traditional | 06/04/2024SE |
| K231061 | NeuroBlate SystemGEX · Traditional | 12/08/2023SE |
| K222983 | NeuroBlate Fusion-S Software V3.17GEX · Traditional | 03/15/2023SE |
| K201056 | NeuroBlate SystemGEX · Traditional | 08/21/2020SE |
| K193375 | NeuroBlate SystemGEX · Special | 01/03/2020SE |
| K182036 | NeuroBlate SystemGEX · Traditional | 10/15/2018SE |
| K173305 | NeuroBlate SystemGEX · Special | 11/17/2017SE |
| K172881 | NeuroBlate SystemGEX · Special | 10/20/2017SE |
Questions and answers
When was Atama System cleared by the FDA?
Atama System (K110411) received a 510(k) decision of Substantially Equivalent on April 8, 2011, 53 days after the submission was received.
What is the product code of K110411?
The FDA product code is MOS – Coil, Magnetic Resonance, Specialty, a Class II (moderate risk) device regulated under 21 CFR 892.1000.