TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T
FDA 510(k) K082636 · Quality Electrodynamics
510(k) numberK082636
Submission
- Device name
- TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T
- Applicant
- Quality Electrodynamics
Mayfield Village, OH, US - Received
- September 10, 2008
- Decision date
- September 25, 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 |
|---|---|---|
| K244054 | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)MOS · Traditional | 02/28/2025SE |
| K242006 | SureWave Elastography (Q7000225)LNH · Traditional | 02/12/2025SE |
| K233652 | Contour Hand/Wrist (Q7000232)MOS · Traditional | 02/16/2024SE |
| K233656 | Contour ShoulderMOS · Traditional | 02/15/2024SE |
| K223429 | Contour KneeMOS · Traditional | 01/13/2023SE |
| K200477 | Flex Body SpeederMOS · Traditional | 04/08/2020SE |
| K193140 | Flex Body SPEEDERMOS · Traditional | 01/03/2020SE |
| K183111 | Contour 24MOS · Traditional | 12/07/2018SE |
| K181697 | 16ch Foot/ Ankle SPEEDERMOS · Traditional | 07/11/2018SE |
| K173469 | 16ch T/R Hand Wrist CoilMOS · Traditional | 01/09/2018SE |
Questions and answers
When was TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T cleared by the FDA?
TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T (K082636) received a 510(k) decision of Substantially Equivalent on September 25, 2008, 15 days after the submission was received.
What is the product code of K082636?
The FDA product code is MOS – Coil, Magnetic Resonance, Specialty, a Class II (moderate risk) device regulated under 21 CFR 892.1000.