Hitachi Echelon NV Attachment and Small Extremity Coils Model Echelon
FDA 510(k) K102889 · Hitachi Medical Systems America, Inc.
510(k) numberK102889
Submission
- Device name
- Hitachi Echelon NV Attachment and Small Extremity Coils Model Echelon
- Applicant
- Hitachi Medical Systems America, Inc.
Twinsburg, OH, US - Received
- September 30, 2010
- Decision date
- December 20, 2010
- 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 |
|---|---|---|
| K163528 | HITACHI Supria Whole-body X-ray CT System Phase 3JAK · Abbreviated | 03/03/2017SE |
| K162079 | TRILLIUM Oval Head Coil 32MOS · Traditional | 09/16/2016SE |
| K161748 | SUPRIA w/guideShot OptionJAK · Abbreviated | 08/17/2016SE |
| K160152 | Trillium Oval V 5.1 MRI SystemLNH · Traditional | 05/20/2016SE |
| K153547 | ECHELON Oval V 5.1 MRI SystemLNH · Special | 03/31/2016SE |
| K150595 | SCENARIA Phase 3 Whole-body X-ray CT SystemJAK · Traditional | 10/30/2015SE |
| K150565 | Supria Whole-body X-ray CT SystemJAK · Traditional | 09/30/2015SE |
| K151015 | ECHELON Oval V 5.0 MRI SystemLNH · Traditional | 07/29/2015SE |
| K143537 | Sirius Starmobile tiaraIZL · Traditional | 03/06/2015SE |
| K142734 | TRILLIUM Oval MR SystemLNH · Traditional | 03/02/2015SE |
Questions and answers
When was Hitachi Echelon NV Attachment and Small Extremity Coils Model Echelon cleared by the FDA?
Hitachi Echelon NV Attachment and Small Extremity Coils Model Echelon (K102889) received a 510(k) decision of Substantially Equivalent on December 20, 2010, 81 days after the submission was received.
What is the product code of K102889?
The FDA product code is MOS – Coil, Magnetic Resonance, Specialty, a Class II (moderate risk) device regulated under 21 CFR 892.1000.