Intercept Esophageal Internal MR Coil, Intercept Urethral Microcoil, and Intercept Vascular Internal MR Coil
FDA 510(k) K020790 · Surgi-Vision, Inc.
510(k) numberK020790
Submission
- Device name
- Intercept Esophageal Internal MR Coil, Intercept Urethral Microcoil, and Intercept Vascular Internal MR Coil
- Applicant
- Surgi-Vision, Inc.
Gaithersburg, MD, US - Received
- March 11, 2002
- Decision date
- May 21, 2002
- 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 |
|---|---|---|
| K111073 | Surgivision Inc. Clearpoint SystemORR · Traditional | 06/22/2011SE |
| K020495 | Intercept Esophageal Internal MR Coil, Intercept Urethral Internal MR Coil, and…MOS · Traditional | 04/23/2002SE |
| K011781 | Intercept-Urethral MicrocoilMOS · Traditional | 08/31/2001SE |
| K003436 | Surgi-Vision Guidewire CoilMOS · Traditional | 02/02/2001SE |
| K002916 | Surgi-Vision Prostate CoilMOS · Traditional | 11/28/2000SE |
| K002345 | Surgi-Vision Urethral CoilMOS · Traditional | 10/11/2000SE |
| K994436 | Surgi-Vision Esophageal Stylet CoilMOS · Traditional | 03/14/2000SE |
| K992193 | Endo-Esophageal MR CoilMOS · Traditional | 09/03/1999SE |
Questions and answers
When was Intercept Esophageal Internal MR Coil, Intercept Urethral Microcoil, and Intercept Vascular Internal MR Coil cleared by the FDA?
Intercept Esophageal Internal MR Coil, Intercept Urethral Microcoil, and Intercept Vascular Internal MR Coil (K020790) received a 510(k) decision of Substantially Equivalent on May 21, 2002, 71 days after the submission was received.
What is the product code of K020790?
The FDA product code is MOS – Coil, Magnetic Resonance, Specialty, a Class II (moderate risk) device regulated under 21 CFR 892.1000.