Cleared Traditional

dS Sentinelle Breast 16ch 1.5T Coil (K213735) - FDA 510(k) Clearance

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

K213735 · Invivo Corporation (Business Trade Name: Philips) · Radiology device
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Aug 2022
Decision
252d
Days
Class 2
Risk

K213735 is an FDA 510(k) clearance for the dS Sentinelle Breast 16ch 1.5T 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 252 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 K213735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2021
Decision Date August 08, 2022
Days to Decision 252 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
145d slower than avg
Panel avg: 107d · This submission: 252d
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 K213735.
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