MOS — Coil, Magnetic Resonance, Specialty Class II
FDA Device Classification
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 |
|---|
| 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 |
| K233600 | philips healthcare (suzhou) co | Smart Fit Knee 3.0T | February 5, 2024 |
| K233444 | inkspace imaging | InkSpace Imaging Small Body Array | January 8, 2024 |
| K233348 | philips medical system nederlands | 16 Breast Coil | October 24, 2023 |
| K232762 | invivo corporation (business trade name: philips) | dS Breast Coil 7ch 1.5T | October 3, 2023 |
| K232021 | philips healthcare (suzhou) co | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T | September 1, 2023 |
| K231085 | shenzhen rf tech co | 1.5T HD T/R Knee Array (10-F34127) | August 18, 2023 |