Cleared Special

TruSPECT Radiological Image Processing Station (K212230) - FDA 510(k) Clearance

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

K212230 · Spectrum Dynamics Medical, Ltd. · Radiology device
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Aug 2021
Decision
31d
Days
Class 2
Risk

K212230 is an FDA 510(k) clearance for the TruSPECT Radiological Image Processing Station. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Spectrum Dynamics Medical, Ltd. (Caesarea, IL). The FDA issued a Cleared decision on August 16, 2021 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Spectrum Dynamics Medical, Ltd. devices

Submission Details

510(k) Number K212230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2021
Decision Date August 16, 2021
Days to Decision 31 days
Submission Type Special
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
76d faster than avg
Panel avg: 107d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

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