MOS — Coil, Magnetic Resonance, Specialty Class II
FDA product code MOS covers "Coil, Magnetic Resonance, Specialty", a Class II medical device regulated under 21 CFR 892.1000. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MOS
- Device Class
- Class II
- Regulation Number
- 892.1000
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K262330 | philips medical systems nederland | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Bre | July 30, 2026 |
| K262294 | philips medical systems nederland | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS H | July 24, 2026 |
| K260947 | neocoil | 0.55T 12Ch Breast Coil | April 23, 2026 |
| K252587 | shenzhen rf tech co | HD 8Ch Wrist Array | April 14, 2026 |
| K252876 | shenzhen rf tech co | GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Rece | April 1, 2026 |
| K260519 | philips healthcare (suzhou) co | Smart Fit TorsoCardiac 1.5T | March 20, 2026 |
| K252179 | shenzhen rf tech co | GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Rece | February 10, 2026 |
| K253738 | ge healthcare coils (usa instruments, inc.) | 3.0T AIR 32CH HNA | January 23, 2026 |
| K254190 | philips medical systems nederland | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS Hea | January 14, 2026 |
| K253182 | inkspace imaging | InkSpace Imaging Small Body Array (SBA12PH30x) | October 20, 2025 |
| K243428 | dxtx medical | e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Co | July 17, 2025 |
| K244054 | quality electrodynamics | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247 | February 28, 2025 |
| K243675 | inkspace imaging | InkSpace Imaging Small Body Array | December 20, 2024 |
| K243316 | polarean | XENOVIEW 3.0T Chest Coil | November 19, 2024 |
| K243033 | philips medical systems nederland | dS Wrist coil 8ch 1.5T | October 18, 2024 |
| K242879 | philips medical systems nederland | dS Knee Coil 8ch 1.5T | October 18, 2024 |
| K242096 | philips medical systems nederland | dS FootAnkle Coil 8ch 1.5T | August 12, 2024 |
| K241069 | noras mri products | iLoop Interventional Coil 0.55T | June 7, 2024 |
| K233652 | quality electrodynamics | Contour Hand/Wrist (Q7000232) | February 16, 2024 |
| K233656 | quality electrodynamics | Contour Shoulder | February 15, 2024 |