510(k) K253738
- Device
- 3.0T AIR 32CH HNA
- Applicant
- Ge Healthcare Coils (Usa Instruments, Inc.)
- 510(k) number
- K253738
- Product code
- MOS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-23
- Date received
- 2025-11-24
- Regulation
- 892.1000
- Classification name
- Coil, Magnetic Resonance, Specialty
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Sahra Nur
- Address
- 1515 Danner Dr. Aurora OH US 44202 44202
FDA Registration Numbers
- 3007562060
- 3004531751
- 3012439308
- 3008355361
- 3006369484
- 3006239787
- 3005049692
- 3009970070
- 3014310698
- 2183744
- 3013875850
- 2029275
- 3011015597
- 3036666444
- 3008986341
- 3014343100
- 1058584
- 3028006458
- 3009514037
- 1835830
- 3010703925
- 3009963139
- 3008284470
- 3015276088
- 3017375271
- 1932898
- 3003768277
- 3032109225
- 3035950510
- 3009529630
- 3010326005
- 3009714754
- 3031503890
- 3004929307
- 3006262888
- 3007137598
- 1054811
- 3014809646
- 3004754211
- 3042177665
- 3009656988
- 3010132318
- 1529041
- 3012169560
- 9614698
- 3009077524
- 3004977335
- 3015431711
- 3027339477
- 3005877899
- 3021244844
- 3029521953
- 3018423337
- 3009755250
- 3014635027
- 3023003446
- 3012085143
- 3021059265
- 3010949642
- 2011171
- 1043549
- 3009196578
- 3008414621
- 3002808157
- 2183553
- 3008632256
- 3000126629
- 9613936
- 3015329423
- 3005326970
- 3016851825
- 9616047
- 3007350713
- 3026047529
- 3011950073
Source Documents
Other 510(k) Records For Product Code MOS
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260947 | 0.55T 12Ch Breast Coil | Neocoil, LLC | 2026-04-23 |
| K252587 | HD 8Ch Wrist Array | Shenzhen RF Tech Co., Ltd. | 2026-04-14 |
| K252876 | GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only | Shenzhen RF Tech Co., Ltd. | 2026-04-01 |
| K260519 | Smart Fit TorsoCardiac 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-20 |
| K252179 | GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only | Shenzhen RF Tech Co., Ltd. | 2026-02-10 |
| K254190 | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T | Philips Medical Systems Nederland B.V. | 2026-01-14 |
| K253182 | InkSpace Imaging Small Body Array (SBA12PH30x) | Inkspace Imaging, Inc. | 2025-10-20 |
| K243428 | e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector | Dxtx Medical, Inc. | 2025-07-17 |
| K244054 | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) | Quality Electrodynamics | 2025-02-28 |
| K243675 | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. | 2024-12-20 |
| K243316 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | 2024-11-19 |
| K243033 | dS Wrist coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | 2024-10-18 |
| K242879 | dS Knee Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | 2024-10-18 |
| K242096 | dS FootAnkle Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | 2024-08-12 |
| K241069 | iLoop Interventional Coil 0.55T | Noras Mri Products GmbH | 2024-06-07 |