FDA.reportPublic FDA data

510(k) DEN170073

Device
ContaCT
Applicant
Viz.Al, Inc.
510(k) number
DEN170073
Product code
QAS
Decision
Unknown (DENG)
Decision date
2018-02-13
Date received
2017-09-29
Regulation
892.2080
Classification name
Radiological Computer-Assisted Triage And Notification Software
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Direct
Third party reviewed
N

Applicant Contact#

Contact
Gregory Ramina
Address
343 Texas St. San Francisco CA US 94301 94301

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code QAS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261317BriefCase-TriageAidoc Medical , Ltd.2026-05-14
K253163EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)Ever Fortune.Ai, Co., Ltd.2026-04-22
K252421JLK-NCCTJLK, Inc.2026-03-24
K253818Annalise EnterpriseHarrison-AI Medical Pty, Ltd.2026-03-03
K253578BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation deviceAidoc Medical , Ltd.2026-02-26
K251195BriefCase-TriageAidoc Medical , Ltd.2026-01-27
K252970BriefCase-Triage: CARE Multi-triage CT BodyAidoc Medical , Ltd.2026-01-07
K250694Scaida BrainCT-ICH (v1.0)Mlhealth 3602025-11-25
K252366a2z-Unified-TriageA2z Radiology Ai, Inc.2025-11-24
K253265BriefCase-TriageAidoc Medical , Ltd.2025-11-06
K251610qER-CTA (v1.0)Qure.Ai Technologies2025-09-08
K251533Rapid Obstructive Hydrocephalus, Rapid OHIschemaview, Inc.2025-09-04
K251983Brainomix 360 Triage StrokeBrainomix Limited2025-08-26
K251590Methinks CTA StrokeMethinks Software, S.L2025-08-20
K251151Rapid CTA 360Ischemaview2025-07-16