Temporomanibular Coil 15
FDA 510(k) K110373 · Esaote, S.p.A.
510(k) numberK110373
Submission
- Device name
- Temporomanibular Coil 15
- Applicant
- Esaote, S.p.A.
Genova, IT - Received
- February 8, 2011
- Decision date
- April 6, 2011
- 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 |
|---|---|---|
| K261331 | I-Genius (100019400)LNH · Traditional | 07/31/2026SE |
| K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)IYN · Traditional | 04/06/2026SE |
| K260746 | S-scan Open (100001800)LNH · Special | 03/27/2026SE |
| K251901 | Magnifico Open (100009900)LNH · Traditional | 03/05/2026SE |
| K253310 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)IYN · Special | 11/25/2025SE |
| K243253 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)IYN · Traditional | 06/18/2025SE |
| K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)IYN · Traditional | 05/16/2025SE |
| K241133 | Magnifico Open (100009900); Magnifico MSK ( 100009910)LNH · Special | 06/26/2024SE |
| K230179 | 6440 MyLabX90IYN · Traditional | 11/29/2023SE |
| K212419 | Magnifico Open, Magnifico MSKLNH · Traditional | 02/04/2022SE |
Questions and answers
When was Temporomanibular Coil 15 cleared by the FDA?
Temporomanibular Coil 15 (K110373) received a 510(k) decision of Substantially Equivalent on April 6, 2011, 57 days after the submission was received.
What is the product code of K110373?
The FDA product code is MOS – Coil, Magnetic Resonance, Specialty, a Class II (moderate risk) device regulated under 21 CFR 892.1000.