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.”
AlgorithmThe device uses pre-trained neural networks and nonadaptive machine learning algorithms for emission-based attenuation correction, trained with clinical and/or artificial data.
source quote (p.7)
“Also includes a new, pre-trained neural networks in the iteration reconstruction process and 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 evaluation 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

48
recalls in product code, 24mo
295
MAUDE reports in code, 12mo
+683%
vs code's own 3-yr baseline
27
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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K212230