TruSPECT Radiological Image Processing Station

K212230

Spectrum Dynamics Medical Ltd · cleared 2021-08-16 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“The TruSPECT is a Nuclear Medicine Software system designed for nuclear medicine images' post processing and further review procedures for detection of the radioisotope tracer uptake in the patient's body. Thus, using a variety of post processing features oriented to specific clinical applications.”

Algorithmdeep learning model which was trained to directly estimate attenuation corrected SPECT images from non-attenuation corrected ones without the use of any anatomical images; pre-trained neural networks in the iteration reconstruction process and traditional algorithms; artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data

source quote (p.5)

“TruCorr enhances the user's ability to visualize the acquired information (by way of a single clear image) - thus optimizing what would otherwise be a disjointed visual comparison. It is an Emission Based attenuation correction application using the deep learning model which was trained to directly estimate attenuation corrected SPECT images from non-attenuation corrected ones without the use of any anatomical images. TruSPECT introduces a new application that focused on specific imaging attenuation technique, using this basic functionality proposed TruSPECT also enhances existing applications to improve their workflow efficiency using both pre-trained neural networks in the iteration reconstruction process and traditional algorithms. Use artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data”

Adaptive (vs locked)No

source quote (p.7)

“Use artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

sample size not stated

endpoints: algorithm's performance; effectiveness of proposed application; scored them using a 5-point Likert scale

standards: NEMA PS3.1 - 3.20, IEC62304, 21CFR 820, ISO 13485

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

295

MAUDE reports in code, 12mo

+683%

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K253532 (decision 2025-12-30) from Spectrum Dynamics Medical, Ltd. for a matching device line ("TruSPECT Processing Station") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K253532
adverse_event_inflection
MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.
first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:99042
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98520
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems, LLC, initiated 2026-01-30): "There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98428
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (Focalyx Technologies, LLC., initiated 2025-12-23): "Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, wh" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98137
…and 21 more.

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).