Cleared Traditional

D-SPECT Scanner, D-SPECT L Scanner (K161740) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161740 · Spectrum Dynamics Medical, Ltd. · Radiology device
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Nov 2016
Decision
133d
Days
Class 2
Risk

K161740 is an FDA 510(k) clearance for the D-SPECT Scanner, D-SPECT L Scanner. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Spectrum Dynamics Medical, Ltd. (North Industrial Park. Caesarea, IL). The FDA issued a Cleared decision on November 4, 2016 after a review of 133 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

Submission Details

510(k) Number K161740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2016
Decision Date November 04, 2016
Days to Decision 133 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 107d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 178
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