Cleared Traditional

K151403 - Positron Emission Tomography (PET) and ...

K151403 is an FDA 510(k) clearance for Positron Emission Tomography (PET) and ..., manufactured by Neusoft Medical Systems Co., Ltd.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K151403 · Neusoft Medical Systems Co., Ltd. · Radiology device
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Nov 2015
Decision
160d
Days
Class 2
Risk

K151403 is an FDA 510(k) clearance for the Positron Emission Tomography (PET) and Computed Tomography (CT) System, Posit.... Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Neusoft Medical Systems Co., Ltd. (Shenyang, CN). The FDA issued a Cleared decision on November 2, 2015 after a review of 160 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 Neusoft Medical Systems Co., Ltd. devices

FDA 510(k) Submission Details - K151403

510(k) Number K151403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2015
Decision Date November 02, 2015
Days to Decision 160 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
53d slower than avg
Panel avg: 107d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 248
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K151403.
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CORTEX ID SUITE
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DISCOVERY IQ
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