dS Sentinelle Breast 16ch 1.5T Coil
by Invivo Corporation (Business Trade Name: Philips)
510(k) K213735
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK213735 | Date8 Aug 2022 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- MOS
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1000
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The dS Sentinelle Breast 16ch 1.5T Coil is a magnetic resonance (MR) breast coil, designed for high-resolution imaging of breast tissue at 1.5 Tesla. It is a 16-channel phased-array coil specifically engineered to enhance signal-to-noise ratio and spatial resolution in breast MRI examinations, improving diagnostic accuracy for conditions such as breast cancer screening and evaluation.
This coil is intended for use in MRI systems operating at 1.5 Tesla and is supplied as a single-use or reusable device, depending on manufacturer guidelines. It is classified as Class II under FDA regulations and has received FDA 510(k) clearance, MDD, and MDR authorizations. Storage and handling must comply with MRI safety protocols, including proper shielding and environmental conditions to prevent interference or damage. The coil is distributed with specific reference codes for traceability and regulatory compliance.
Other devices from Invivo Corporation (Business Trade Name: Philips)
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the dS Sentinelle Breast 16ch 1.5T Coil in MRI imaging?
The dS Sentinelle Breast 16ch 1.5T Coil is designed specifically to enhance breast MRI imaging at 1.5 Tesla by improving signal-to-noise ratio and spatial resolution. This 16-channel phased-array coil helps radiologists achieve higher diagnostic accuracy for conditions like breast cancer screening and evaluation, making it ideal for detailed breast tissue assessment.
How should the dS Sentinelle Breast 1.5T Coil be handled to ensure MRI safety and proper functionality?
The coil must be stored and handled according to MRI safety protocols, including proper shielding and environmental conditions to prevent interference or damage. Since it is intended for use in 1.5 Tesla MRI systems, compliance with these guidelines ensures optimal performance and safety during imaging procedures.
Is the dS Sentinelle Breast 16ch 1.5T Coil reusable, or is it intended for single-use only?
The coil can be used either as a single-use or reusable device, depending on the manufacturer’s guidelines. This flexibility allows facilities to choose the most cost-effective and practical approach for their workflow while maintaining imaging quality.
What regulatory pathways has the dS Sentinelle Breast 16ch 1.5T Coil undergone, and what does this mean for its use?
The coil has received FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) authorizations. This indicates it has been evaluated for safety and performance under applicable regulations, ensuring compliance with international and U.S. standards for medical device approval.
Are there multiple versions or sizes of the dS Sentinelle Breast 16ch 1.5T Coil, or is it a single standardized model?
The coil is primarily described as a 16-channel phased-array coil for 1.5 Tesla MRI systems, with no explicit mention of multiple sizes or models in the provided data. However, the listed registration numbers suggest multiple variants or configurations may exist, though their specifics would require further manufacturer documentation.