ds Head 32ch 3.0T
FDA 510(k) K213351 · Invivo Corporation (Business Trade Name: Philips)
510(k) numberK213351
Submission
- Device name
- ds Head 32ch 3.0T
- Applicant
- Invivo Corporation (Business Trade Name: Philips)
Florida, FL, US - Received
- October 8, 2021
- Decision date
- October 29, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K232762 | dS Breast Coil 7ch 1.5TMOS · Special | 10/03/2023SE |
| K222325 | 8ch Wrist CoilMOS · Traditional | 08/31/2022SE |
| K222257 | 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee CoilMOS · Traditional | 08/23/2022SE |
| K213735 | dS Sentinelle Breast 16ch 1.5T CoilMOS · Traditional | 08/08/2022SE |
| K213727 | dS Sentinelle Breast 16ch 3.0T CoilMOS · Traditional | 08/08/2022SE |
Questions and answers
When was ds Head 32ch 3.0T cleared by the FDA?
ds Head 32ch 3.0T (K213351) received a 510(k) decision of Substantially Equivalent on October 29, 2021, 21 days after the submission was received.
What is the product code of K213351?
The FDA product code is MOS – Coil, Magnetic Resonance, Specialty, a Class II (moderate risk) device regulated under 21 CFR 892.1000.