FDA-cleared profile
EXINI Diagnostics AB
Authorized purpose: aBSI analyzes nuclear-medicine whole-body bone scans and SPECT to mark lesions and quantify skeletal disease burden as a fraction of total skeletal weight for trained professionals and researchers; the cloud release does not accept CT or static partial bone scans.
Product overview
Authorized purpose: aBSI analyzes nuclear-medicine whole-body bone scans and SPECT to mark lesions and quantify skeletal disease burden as a fraction of total skeletal weight for trained professionals and researchers; the cloud release does not accept CT or static partial bone scans.
Overview status: Source-reviewed overview
Clinical role: aBSI analyzes nuclear-medicine whole-body bone scans and SPECT to mark lesions and quantify skeletal disease burden as a fraction of total skeletal weight for trained professionals and researchers; the cloud release does not accept CT or static partial bone scans.
Evidence from the reviewed source record: K191262 reports analytical, reproducibility, phantom, and two clinical studies. In a 721-patient phase III analysis, baseline aBSI was associated with overall survival and remained independently associated after adjustment; a separate 169-patient analysis found that an aBSI increase of 0.6 had the same 0.52 association with time to radiographic bone progression as PCWG criteria.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
The exact subject-device comparison provides the DICOM 3 input types and the CT/static-partial boundary.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
The exact software-risk discussion states this consequence boundary; the packet does not state the prior threshold, acquisition, urinary-activity, or standalone-diagnosis wording.
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.
The exact indication names nuclear-medicine imaging and the subject-device comparison lists DICOM 3 whole-body bone scans and SPECT; it does not support the dossier's PET wording. Controlled directory display reconciled from exact FDA wording: Nuclear medicine (NM) imaging, including DICOM 3 whole-body bone scans and SPECT. -> PET/SPECT/Nuclear Medicine.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Confirm the controls against the exact contracted architecture and release.
Map the installed model, build, options, population, anatomy, inputs, and outputs to K191262 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
Cloud service accessed through a personal login on Windows or macOS Chrome, with image upload from a local or network folder; validate DICOM transfer, identity, patient matching, longitudinal alignment, browser support, and result export.
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. aBSI is quantitative decision support, not a standalone metastasis diagnosis. Threshold-dependent staging performance can trade sensitivity against specificity, and scan counts, acquisition speed, urinary activity, protocol, and disease burden can affect results.
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: aBSI is quantitative decision support, not a standalone metastasis diagnosis. Threshold-dependent staging performance can trade sensitivity against specificity, and scan counts, acquisition speed, urinary activity, protocol, and disease burden can affect results.
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 quantitative-biomarker 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 quantitative-biomarker function. Use the task-specific endpoints and tested population reported below.
721 patients
1.2 hazard ratio
1.06 hazard ratio
0.52 Kendall tau
0.995 Pearson r
0.96 kappa
100 %
36.2 %
K191262
Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.
PMC4975929
Algorithm-family evidence with an earlier version; includes a documented bladder-region blind spot.
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.
The refreshed discovery snapshot contains 20 PubMed and 10 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. 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, peer reviewed publication, reimbursement policy, fda device recall, fda decision summary packet, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: purpose, anatomy, intendedUsers, output, evidenceSummary, modality, input, limitations, clinicalUse
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Scope: limitations, evidenceSummary, evidenceStudy, evidenceMetrics, monitoring
Scope: limitations, evidenceSummary, evidenceStudy, evidenceMetrics, monitoring
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Source-reviewed editorial overlay
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