Cleared Traditional

K232021 - Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T

K232021 is an FDA 510(k) clearance for Smart Fit TorsoCardiac 1.5T and Smart F..., manufactured by Philips Healthcare (Suzhou) Co., Ltd.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K232021 · Philips Healthcare (Suzhou) Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
56d
Days
Class 2
Risk

K232021 is an FDA 510(k) clearance for the Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T. 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 September 1, 2023 after a review of 56 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

FDA 510(k) Submission Details - K232021

510(k) Number K232021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2023
Decision Date September 01, 2023
Days to Decision 56 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 107d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOS Device Classification - Class 2, Special Controls

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 399
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