510(k) K211658
- Device
- OR Head Holder LUCY With HeadCoilSet Siemens 1.5T, OR Head Holder LUCY With HeadCoilSet Siemens 3T, OR Head Holder LUCY With HeadCoilSet Philips 1.5T, OR Head Holder LUCY With HeadCoilSet Philips 3T
- Applicant
- NORAS MRI Products GmbH
- 510(k) number
- K211658
- Product code
- MOS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-03-03
- Date received
- 2021-05-28
- Regulation
- 892.1000
- Classification name
- Coil, Magnetic Resonance, Specialty
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Manuel Noras
- Address
- Leibnizstr. 4 Hoechberg DE 97204 97204
FDA Registration Numbers#
- 3008355361
- 3008284470
- 3008986341
- 3014343100
- 3010949642
- 3015329423
- 3015276088
- 3011015597
- 3018423337
- 3032109225
- 2183553
- 3009656988
- 3007562060
- 3009963139
- 3004531751
- 3015431711
- 9616047
- 3035950510
- 1932898
- 9614698
- 3026047529
- 3004929307
- 3014310698
- 3042177665
- 3005877899
- 3007350713
- 3004754211
- 3036666444
- 2183744
- 3010326005
- 3029521953
- 3027339477
- 3023003446
- 2029275
- 3002808157
- 3008414621
- 3004977335
- 1058584
- 3007137598
- 3010703925
- 3012169560
- 3005049692
- 1529041
- 3009970070
- 3006369484
- 3009196578
- 3009077524
- 1043549
- 3028006458
- 9613936
- 1835830
- 3009755250
- 3014809646
- 3017375271
- 3010132318
- 3031503890
- 3009714754
- 3013875850
- 3021244844
- 3014635027
- 3012085143
- 3009514037
- 3003768277
- 3000126629
- 3006262888
- 2011171
- 3006239787
- 3012439308
- 3009529630
- 3005326970
- 3011950073
- 3008632256
- 3021059265
- 3016851825
- 1054811
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 |
| K253738 | 3.0T AIR 32CH HNA | Ge Healthcare Coils (Usa Instruments, Inc.) | 2026-01-23 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases