Cleared Traditional

dS Sentinelle Breast 16ch 3.0T Coil (K213727) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213727 · Invivo Corporation (Business Trade Name: Philips) · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
255d
Days
Class 2
Risk

K213727 is an FDA 510(k) clearance for the dS Sentinelle Breast 16ch 3.0T Coil. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Invivo Corporation (Business Trade Name: Philips) (Florida, US). The FDA issued a Cleared decision on August 8, 2022 after a review of 255 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Invivo Corporation (Business Trade Name: Philips) devices

Submission Details

510(k) Number K213727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2021
Decision Date August 08, 2022
Days to Decision 255 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 107d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MOS Coil, Magnetic Resonance, Specialty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MOS Coil, Magnetic Resonance, Specialty

All 94
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K213727.
16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil
K222407 · Neocoil, LLC · Oct 2022
8ch Wrist Coil
K222325 · Invivo Corporation (Business Trade Name: Philips) · Aug 2022
1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil
K222257 · Invivo Corporation (Business Trade Name: Philips) · Aug 2022
dS Sentinelle Breast 16ch 1.5T Coil
K213735 · Invivo Corporation (Business Trade Name: Philips) · Aug 2022
Breast BI Coil Set 0.55T
K220144 · Noras Mri Products GmbH · Apr 2022
32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch
K213687 · Neocoil, LLC · Mar 2022