dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T
FDA 510(k) K212864 · Philips Healthcare (Suzhou) Co., Ltd.
510(k) numberK212864
Submission
- Device name
- dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T
- Applicant
- Philips Healthcare (Suzhou) Co., Ltd.
Suzhou, CN - Received
- September 8, 2021
- Decision date
- December 1, 2021
- 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 |
|---|---|---|
| K252992 | CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional | 03/23/2026SE |
| K260519 | Smart Fit TorsoCardiac 1.5TMOS · Special | 03/20/2026SE |
| K242329 | CT Collaboration LiveLLZ · Traditional | 11/18/2024SE |
| K232491 | CT 5300JAK · Traditional | 05/03/2024SE |
| K233600 | Smart Fit Knee 3.0TMOS · Traditional | 02/05/2024SE |
| K232021 | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TMOS · Traditional | 09/01/2023SE |
| K223311 | Philips CT 3500JAK · Traditional | 12/22/2022SE |
| K212441 | Philips Incisive CTJAK · Traditional | 04/27/2022SE |
| K211168 | Philips Incisive CT on TrailerJAK · Traditional | 11/22/2021SE |
| K203514 | Precise PositionJAK · Traditional | 06/17/2021SE |
Questions and answers
When was dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T cleared by the FDA?
dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T (K212864) received a 510(k) decision of Substantially Equivalent on December 1, 2021, 84 days after the submission was received.
What is the product code of K212864?
The FDA product code is MOS – Coil, Magnetic Resonance, Specialty, a Class II (moderate risk) device regulated under 21 CFR 892.1000.