JLK-ICH

Evidence summary

Standalone retrospective study of 376 US NCCTs (188 ICH-positive, 188 negative) with two ABR-certified neuroradiologists and third-reader consensus. Test data were newly acquired and independent of development data.

FDA source Exact FDA submission Checked 2026-09-05

• Source

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.

• Verify care setting and population: Confirm the intended care setting, patient population, and service line.
• Verify security and privacy controls: No current scoped security or mobile-device attestation reviewed.
• Verify training: Mobile-app notification response training and local escalation protocol remain unestablished.
• Verify pricing and total cost: No primary-source US commercial price reviewed.
• Verify reimbursement and coding relevance: No applicable payer policy reviewed; overseas procurement mentions do not establish US coverage.
• Verify local validation and lifecycle monitoring: Local notification latency, false-alert and missed-alert monitoring commitments require confirmation.
• 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.

Stored PubMed candidate and publication metadata/full-text record reviewed; it names JLK-ICH but has company-employed authors and unestablished exact version, so retained only as non-independent product-family context. Stored trial array is empty. The current discovery snapshot contains 1 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, peer reviewed publication, trial registry, recall database, pubmed, clinical trials, openfda device recall

• JLK-ICH: K243363 decision and 510(k) summary U.S. Food and Drug Administration · 2026-09-05
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• Jlk-ich model card (K243363) American College of Radiology · 2026-09-01
• PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
• ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• JLK-ICH: K243363 decision and 510(k) summary U.S. Food and Drug Administration · 2026-09-05
• MEDIHUB STROKE JLK · 2026-09-05
• Deep learning-assisted detection of intracranial hemorrhage: validation and impact on reader performance Neuroradiology / PubMed · 2026-09-06