Authorized purpose: JLK-SDH analyzes non-contrast head CT for suspected hemispheric subdural hemorrhage and sends notification to a clinician for review in parallel to standard care; PACS/mobile previews may be compressed and are non-diagnostic, while full patient evaluation and uncompressed diagnostic viewing remain required.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: JLK-SDH analyzes non-contrast head CT for suspected hemispheric subdural hemorrhage and sends notification to a clinician for review in parallel to standard care; PACS/mobile previews may be compressed and are non-diagnostic, while full patient evaluation and uncompressed diagnostic viewing remain required.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: JLK-SDH analyzes non-contrast head CT for suspected hemispheric subdural hemorrhage and sends notification to a clinician for review in parallel to standard care; PACS/mobile previews may be compressed and are non-diagnostic, while full patient evaluation and uncompressed diagnostic viewing remain required.
Which images or clinical context are in scope?Modality: CT/CTA Anatomy or clinical context: Head Input: Non-contrast head CT in DICOM format; the reviewed labeling does not state a narrower scanner, slice-thickness, or reconstruction requirement.
Who uses it?Intended users: Trained radiologists and clinicians responsible for reviewing suspected subdural hemorrhage
What does the software produce?Output: A notification that suspected subdural hemorrhage has been identified and should be reviewed; previews may be compressed through PACS and mobile applications, while diagnostic review uses non-compressed images.
What is its most important limitation?Key limitation: Notification is not diagnostic and cannot replace full patient evaluation, uncompressed diagnostic image review, standard care, or physician judgment.
Clinical takeaway
Clinical role: JLK-SDH analyzes non-contrast head CT for suspected hemispheric subdural hemorrhage and sends notification to a clinician for review in parallel to standard care; PACS/mobile previews may be compressed and are non-diagnostic, while full patient evaluation and uncompressed diagnostic viewing remain required.
Evidence takeaway
Evidence from the reviewed source record: Independent test used 560 non-contrast head CT scans, including 174 subdural hemorrhage-positive and 386 negative cases; training used 29,524 scans from U.S., Brazilian, and Korean institutions.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
JLK-SDH analyzes non-contrast head CT for suspected hemispheric subdural hemorrhage and sends notification to a clinician for review in parallel to standard care; PACS/mobile previews may be compressed and are non-diagnostic, while full patient evaluation and uncompressed diagnostic viewing remain required.
A notification that suspected subdural hemorrhage has been identified and should be reviewed; previews may be compressed through PACS and mobile applications, while diagnostic review uses non-compressed images.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
The FDA submission describes DICOM-compliant processing, PACS preview, mobile notification, and a JLK-hosted algorithm service; local interfaces and routing require confirmation.
No scoped current security, data-flow, access-control, retention, or incident-response documentation was established.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-07
Current onboarding, competency, and support commitments were not established.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-07
Local acceptance testing, production monitoring, update control, and drift review were not established.
PACS and mobile notification workflow
The exact submission describes a JLK-hosted DICOM service that can send notifications and provide compressed previews through PACS and mobile applications while directing clinicians to uncompressed diagnostic review.
JLK's official MEDIHUB Stroke page describes a family platform spanning CT, CTA, MRI, and MRA algorithms, including JLK-ICH and JLK-LVO; current JLK-SDH packaging and local integration require confirmation.
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.
Evidence summary
Independent test used 560 non-contrast head CT scans, including 174 subdural hemorrhage-positive and 386 negative cases; training used 29,524 scans from U.S., Brazilian, and Korean institutions.
DesignRetrospective test set evaluation with separate multicountry training dataset
Population560 test-set head CT scans; training set contained 29,524 scans from U.S., Brazil, and Korea
Scopeexact submission
Tested versionJLK-SDH submitted in K243611; build not stated
Samplen=560
IndependenceIndependence not established
K243611
The FDA describes the test set as independent of training data and includes 174 SDH-positive and 386 negative cases; independence of investigators or sponsorship was not established.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-07
No public amount, range, currency, geography, or contract term was established.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-09-07
No payer or CMS policy review was performed in this worker cohort.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Postmarket safety review
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-04
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
Verify security and privacy controls: No scoped current security, data-flow, access-control, retention, or incident-response documentation was established.
Verify training: Current onboarding, competency, and support commitments were not established.
Verify pricing and total cost: No public amount, range, currency, geography, or contract term was established.
Verify reimbursement and coding relevance: No payer or CMS policy review was performed in this worker cohort.
Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, update control, and drift review were not established.
Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-07Last searched
26Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
No stored PubMed or ClinicalTrials.gov candidate identifiers for this submission in the 2026-09-01 snapshot; exact-submission recall candidate review was also zero. This metadata screen is not a full paper review. The current discovery snapshot contains 0 PubMed and 0 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, acr ai central product, vendor product page, literature index, trial registry, fda device recall, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history7 sources - 3 history items
Enhanced Boundary for PCCT is a deep-learning CT processing function for improved soft-tissue delineation in routine head examinations with or without contrast.