Cleared Traditional

K212441 - Philips Incisive CT

K212441 is the FDA 510(k) clearance for Philips Incisive CT by Philips Healthcare (Suzhou) Co., Ltd.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K212441 · Philips Healthcare (Suzhou) Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
266d
Days
Class 2
Risk

K212441 is an FDA 510(k) clearance for the Philips Incisive CT. 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 April 27, 2022 after a review of 266 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

Submission Details

510(k) Number K212441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2021
Decision Date April 27, 2022
Days to Decision 266 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
159d slower than avg
Panel avg: 107d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 581
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K212441.
NewTom 7G
K220664 · Cefla S.C. · May 2022
Liver Suite
K211180 · GE Medical Systems SCS · May 2022
BodyTom 64
K213649 · Neurologica Corporation · Apr 2022
HealthOST
K213944 · Nanoxai , Ltd. · Apr 2022
Syngo.CT Dual Energy
K212889 · Siemens Medical Solutions USA, Inc. · Mar 2022
CardIQ Suite
K213725 · GE Medical Systems SCS · Mar 2022