Octave Speeder Head
FDA 510(k) K121910 · Toshiba Medical Systems Corporation, Japan
510(k) numberK121910
Submission
- Device name
- Octave Speeder Head
- Applicant
- Toshiba Medical Systems Corporation, Japan
Tustin, CA, US - Received
- June 29, 2012
- Decision date
- August 17, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K172878 | Vantage Titan 3T, MRT-3010/A7, M-Power GXLNH · Traditional | 11/17/2017SE |
| K133324 | Suresubtraction LungJAK · Traditional | 09/05/2014SE |
| K121911 | Octave Speeder SpineMOS · Special | 08/17/2012SE |
| K121577 | Aplio Artida Diagnostic Ultrasound SystemIYN · Special | 06/22/2012SE |
| K120546 | Aquilion PremiumJAK · Special | 06/13/2012SE |
| K112054 | Infinix Cf-I/Sp and Infinix Vf-I/Sp Model INFX-8000VJAA · Special | 08/05/2011SE |
| K102489 | Vantage Titan 3TLNH · Traditional | 08/02/2011SE |
| K103645 | Aplio XG Diagnostic Ultrasound SystemITX · Special | 01/12/2011SE |
Questions and answers
When was Octave Speeder Head cleared by the FDA?
Octave Speeder Head (K121910) received a 510(k) decision of Substantially Equivalent on August 17, 2012, 49 days after the submission was received.
What is the product code of K121910?
The FDA product code is MOS – Coil, Magnetic Resonance, Specialty, a Class II (moderate risk) device regulated under 21 CFR 892.1000.