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dS Sentinelle Breast 16ch 3.0T Coil

by Invivo Corporation (Business Trade Name: Philips)

510(k) K213727

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213727↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK213727 Date8 Aug 2022ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The dS Sentinelle Breast 16ch 3.0T Coil is a magnetic resonance (MR) specialty coil designed for breast imaging. It is intended for use in 3.0 Tesla MRI systems to enhance signal detection and improve image quality during breast examinations, facilitating better visualization of breast tissue for diagnostic purposes.

This coil is supplied as a reusable device and is compatible with 3.0 Tesla MRI systems. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance, along with compliance under the Medical Device Directive (MDD) and Medical Device Regulation (MDR). The coil is intended for use in radiology settings and requires proper handling and maintenance to ensure MRI safety and performance.

Other devices from Invivo Corporation (Business Trade Name: Philips)

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the dS Sentinelle Breast 16ch 3.0T Coil in breast imaging?

    The dS Sentinelle Breast 16ch 3.0T Coil is specifically designed to enhance signal detection and improve image quality during breast MRI examinations at 3.0 Tesla. By doing so, it helps radiologists achieve better visualization of breast tissue, which aids in more accurate diagnostic evaluations.

  • Is this coil reusable, and if so, what maintenance considerations should be taken into account?

    Yes, the dS Sentinelle Breast 16ch 3.0T Coil is supplied as a reusable device. Since it is intended for use in MRI systems, proper handling and maintenance are critical to ensure MRI safety and performance. This includes regular cleaning, inspection for damage, and adherence to manufacturer guidelines to prevent signal degradation or interference.

  • What type of MRI systems is this coil compatible with, and does it require any specific system configuration?

    The coil is explicitly designed for use in 3.0 Tesla MRI systems. It is not compatible with lower-field or higher-field systems unless explicitly stated otherwise. The coil’s 16-channel configuration is optimized for high-resolution breast imaging on compatible 3.0T platforms, ensuring enhanced diagnostic clarity.

  • How is the regulatory status of this device categorized, and what does that mean for purchasing or clinical use?

    The dS Sentinelle Breast 16ch 3.0T Coil is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance, indicating it is deemed substantially equivalent to a legally marketed predicate device. It also complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) in Europe. This classification means it undergoes rigorous review for safety and effectiveness before market authorization, ensuring it meets established standards for clinical use.

  • Are there multiple models or variations of this coil, or is it a single standardized unit?

    The provided data does not specify multiple distinct models of the dS Sentinelle Breast 16ch 3.0T Coil, but it lists numerous FEI numbers and registration numbers, which may correspond to variations in manufacturing batches, configurations, or regional compliance requirements. However, the core design remains consistent as a 16-channel coil for 3.0T breast MRI. For exact model variations, consulting the manufacturer’s documentation or support team is recommended.