Cleared Abbreviated

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364) (K230600) - FDA 510(k) Clearance

Also marketed or referenced as:
VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K230600 · Spectrum Dynamics Medical, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
56d
Days
Class 2
Risk

K230600 is an FDA 510(k) clearance for the VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364). 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 April 28, 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 892.1200 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Spectrum Dynamics Medical, Ltd. devices

Submission Details

510(k) Number K230600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2023
Decision Date April 28, 2023
Days to Decision 56 days
Submission Type Abbreviated
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
Standards-based clearance path.

Device Classification

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

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