Cleared Traditional

K190457 - VERITON CT whole body SPECT/CT system

K190457 is an FDA 510(k) clearance for VERITON CT whole body SPECT/CT system, manufactured by Spectrum Dynamics Medical, Ltd.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K190457 · Spectrum Dynamics Medical, Ltd. · Radiology device
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Jul 2019
Decision
137d
Days
Class 2
Risk

K190457 is an FDA 510(k) clearance for the VERITON CT whole body SPECT/CT system. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Spectrum Dynamics Medical, Ltd. (Caesarea, IL). The FDA issued a Cleared decision on July 12, 2019 after a review of 137 days - within the typical 510(k) review window.

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 Spectrum Dynamics Medical, Ltd. devices

FDA 510(k) Submission Details - K190457

510(k) Number K190457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2019
Decision Date July 12, 2019
Days to Decision 137 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
30d slower than avg
Panel avg: 107d · This submission: 137d
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 K190457.
Biograph Horizon
K193178 · Siemens Medical Solution USA, Inc. · Feb 2020
Emission Computed Tomography System
K193241 · Shanghai United Imaging Healthcare Co., Ltd. · Jan 2020
Cartesion Prime
K191582 · Canon Medical Systems Corporation · Aug 2019
Biograph Vision
K190900 · Siemens Medical Solutions USA, Inc. · May 2019
Emission Computed Tomography System
K182938 · Shanghai United Imaging Healthcare Co., Ltd. · Dec 2018
SubtlePET
K182336 · Subtle Medical, Inc. · Nov 2018