Vendor
5 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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JLK, Inc.
Authorized purpose: Notification-only triage of adult non-contrast head CT for suspected intracranial hemorrhage and large-vessel occlusion, with parallel communication to trained clinicians during standard care.
JLK, Inc.
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.
JLK, Inc.
Authorized purpose: Notification-only triage of suspected intracranial hemorrhage on non-contrast head CT
JLK, Inc.
Authorized purpose: Notification-only parallel workflow analysis of acute brain CTA to identify suspected large-vessel occlusion in the terminal ICA or MCA-M1 and notify a neurovascular specialist for image review; the finding is not for diagnosis beyond notification.
JLK Inc.
Authorized purpose: Assist trained radiologists and urologists in reviewing and analyzing prostate MR studies through semi-automatic prostate outlining, multiparametric visualization, and related measurements and reporting; patient-management decisions must not rely on the software alone.