FDA-cleared profile
Spectrum Dynamics Medical, Ltd.
Authorized purpose: VERITON CT 300/400 Series combines SPECT and CT for detection, localization, diagnosis, staging, restaging, organ-function assessment, therapy planning, guidance, and monitoring. Optional VERITAS.AI applies locked noise-reduction models to reconstructed SPECT images.
Product overview
Authorized purpose: VERITON CT 300/400 Series combines SPECT and CT for detection, localization, diagnosis, staging, restaging, organ-function assessment, therapy planning, guidance, and monitoring. Optional VERITAS.AI applies locked noise-reduction models to reconstructed SPECT images.
Overview status: Source-reviewed overview
Clinical role: VERITON CT 300/400 Series combines SPECT and CT for detection, localization, diagnosis, staging, restaging, organ-function assessment, therapy planning, guidance, and monitoring. Optional VERITAS.AI applies locked noise-reduction models to reconstructed SPECT images.
Evidence from the reviewed source record: Exact-submission testing used a 30-patient held-out evaluation set and reported strong lesion-signal preservation with lower background variability after noise reduction. The evidence is manufacturer generated and must be supplemented with local quantitative and reader acceptance.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Added in P2 round17 from the exact FDA decision material; later product-family claims remain separate.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Public materials reviewed for this batch do not establish the complete security posture for the exact release. Request data-flow, identity, audit, encryption, retention, support-access, vulnerability-management, backup, and incident-response evidence.
Map the installed model, build, options, population, anatomy, inputs, and outputs to K254001 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
Hybrid SPECT/CT console and DICOM imaging environment; verify quantitative calibration, tracer protocols, workstation routing, and dosimetry round trips.
exact submission · checked 2026-09-03Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.
Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. VERITAS.AI preserves the original reconstruction and is not authorized to change raw data, quantitative values, or dosimetry. Bone-IQ.AI, Thera-IQ.AI, and MIBG-IQ.AI must be used only in their labeled tracer and workflow scopes.
exact submission · checked 2026-09-03Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.
product family · checked 2026-09-03Vendor productivity claims are scenario inputs, not guaranteed local savings.
Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track the limits that matter for this product: VERITAS.AI preserves the original reconstruction and is not authorized to change raw data, quantitative values, or dosimetry. Bone-IQ.AI, Thera-IQ.AI, and MIBG-IQ.AI must be used only in their labeled tracer and workflow scopes.
exact submission · checked 2026-09-03Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
Sensitivity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or dose-delivery function. Use the task-specific endpoints and tested population reported below.
Specificity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or dose-delivery function. Use the task-specific endpoints and tested population reported below.
0.99 R-squared
0.94 slope
0.99 R-squared
0.99 slope
28 %
20 %
K254001
Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, enabled features, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
A zero-result exact-identifier search does not prove that no recall, correction, adverse-event report, or product-family safety signal exists.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Twenty PubMed records and ten trial records were screened. None identifies the VERITON CT 300/400 Series with the K254001 VERITAS.AI release. No evidence was promoted, and all 30 candidates remain quarantined. The current discovery snapshot contains 20 PubMed and 10 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, vendor product page, reimbursement policy, fda device recall, fda decision material, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: identity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Scope: productFamily, workflowRole, implementationCapabilities, currentCommercialContext
Regulatory record
510(k)
Research record
human reviewed
Editorial review
Source-reviewed editorial overlay
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