Pediatric Body-Cardiac Coil, Model: 5000012601
FDA 510(k) K101949 · Shanghai Chenguang Medical Technologies Co, Ltd.
510(k) numberK101949
Submission
- Device name
- Pediatric Body-Cardiac Coil, Model: 5000012601
- Applicant
- Shanghai Chenguang Medical Technologies Co, Ltd.
Shanghai, CN - Received
- July 12, 2010
- Decision date
- July 28, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K112002 | Carotid CoilMOS · Traditional | 11/18/2011SE |
| K101858 | Pediatric Head-Spine Coil (MODEL:5000012701MOS · Traditional | 07/14/2010SE |
| K092962 | Carotid Coil 5000004901MOS · Traditional | 10/09/2009SE |
| K081340 | Pediatric Body and Cardiac Coil, Model 01000140201MOS · Traditional | 06/18/2008SE |
| K081322 | Magnetic Resonance Diagnostic Device, Model 0100140201, Pediatric Head-Spine CoilMOS · Traditional | 06/18/2008SE |
| K071847 | Magnetic Resonance Diagnostic Device, Model CG-KFC18-H150-AP - Knee/Foot/Ankle CoilMOS · Traditional | 07/23/2007SE |
| K071882 | Model CG-WHC18-H150-AP - Wrist Hand Coil 1.5T 4 CH,MOS · Traditional | 07/18/2007SE |
Questions and answers
When was Pediatric Body-Cardiac Coil, Model: 5000012601 cleared by the FDA?
Pediatric Body-Cardiac Coil, Model: 5000012601 (K101949) received a 510(k) decision of Substantially Equivalent on July 28, 2010, 16 days after the submission was received.
What is the product code of K101949?
The FDA product code is MOS – Coil, Magnetic Resonance, Specialty, a Class II (moderate risk) device regulated under 21 CFR 892.1000.