Cleared Traditional

K233600 - Smart Fit Knee 3.0T

K233600 is the FDA 510(k) clearance for Smart Fit Knee 3.0T by Philips Healthcare (Suzhou) Co., Ltd.. It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K233600 · Philips Healthcare (Suzhou) Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
88d
Days
Class 2
Risk

K233600 is an FDA 510(k) clearance for the Smart Fit Knee 3.0T. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Philips Healthcare (Suzhou) Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on February 5, 2024 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Philips Healthcare (Suzhou) Co., Ltd. devices

Submission Details

510(k) Number K233600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2023
Decision Date February 05, 2024
Days to Decision 88 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
19d faster than avg
Panel avg: 107d · This submission: 88d
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 298
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K233600.
iLoop Interventional Coil 0.55T
K241069 · Noras Mri Products GmbH · Jun 2024
Contour Hand/Wrist (Q7000232)
K233652 · Quality Electrodynamics · Feb 2024
Contour Shoulder
K233656 · Quality Electrodynamics · Feb 2024
InkSpace Imaging Small Body Array
K233444 · Inkspace Imaging, Inc. · Jan 2024
16 Breast Coil
K233348 · Philips Medical System Nederlands B.V. · Oct 2023
dS Breast Coil 7ch 1.5T
K232762 · Invivo Corporation (Business Trade Name: Philips) · Oct 2023