Cleared Traditional

K232491 - CT 5300

K232491 is an FDA 510(k) clearance for CT 5300, manufactured by Philips Healthcare (Suzhou) Co., Ltd.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K232491 · Philips Healthcare (Suzhou) Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
260d
Days
Class 2
Risk

K232491 is an FDA 510(k) clearance for the CT 5300. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Philips Healthcare (Suzhou) Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on May 3, 2024 after a review of 260 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 Philips Healthcare (Suzhou) Co., Ltd. devices

FDA 510(k) Submission Details - K232491

510(k) Number K232491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2023
Decision Date May 03, 2024
Days to Decision 260 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
153d slower than avg
Panel avg: 107d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 715
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K232491.
HiRise (1040-230)
K241713 · Curvebeam, LLC · Jul 2024
OmniTom Elite
K233767 · Neurologica Corporation · Jun 2024
Brainomix 360 e-Lung
K233875 · Brainomix Limited · May 2024
FCT iSTREAM Phase 1
K233583 · Fujifilm Healthcare Americas Corporation · Apr 2024
True Enhance DL
K233698 · Ge Healthcare Japan Corporation · Apr 2024
ABLATE-IQ
K232227 · Neuwave Medical, Inc. · Apr 2024