16CH Ai Breast Coils 1.5 T and 3 T
FDA 510(k) K083255 · Rapid Biomedical GmbH
510(k) numberK083255
Submission
- Device name
- 16CH Ai Breast Coils 1.5 T and 3 T
- Applicant
- Rapid Biomedical GmbH
Rimpar, DE - Received
- November 4, 2008
- Decision date
- November 21, 2008
- 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 |
|---|---|---|
| K213480 | 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head CoilMOS · Traditional | 02/01/2023SE |
| K191539 | 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil SupportMOS · Traditional | 01/31/2020SE |
| K181948 | 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast CoilMOS · Traditional | 11/16/2018SE |
| K163661 | P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex CoilMOS · Traditional | 03/21/2018SE |
| K102748 | 31P/1H Head Coil 3T; 23NA/1H Head Coil 3T; 13C/1H Head Coil 3TMOS · Abbreviated | 05/13/2011SE |
| K102348 | 31P/1H Dual Tuned Surface Coil 3T; 23NA/ 1H Dual Turned Surface Coil 3T; 13C /1H Dual…MOS · Abbreviated | 12/22/2010SE |
Questions and answers
When was 16CH Ai Breast Coils 1.5 T and 3 T cleared by the FDA?
16CH Ai Breast Coils 1.5 T and 3 T (K083255) received a 510(k) decision of Substantially Equivalent on November 21, 2008, 17 days after the submission was received.
What is the product code of K083255?
The FDA product code is MOS – Coil, Magnetic Resonance, Specialty, a Class II (moderate risk) device regulated under 21 CFR 892.1000.