Accipiolx

Radiological Computer-assisted Triage And Notification Software

MaxQ-Al Ltd.

The following data is part of a premarket notification filed by Maxq-al Ltd. with the FDA for Accipiolx.

Pre-market Notification Details

Device IDK182177
510k NumberK182177
Device Name:Accipiolx
ClassificationRadiological Computer-assisted Triage And Notification Software
Applicant MaxQ-Al Ltd. 76 Yigal Alon Street, 5th Floor Tel Aviv,  IL 6706701
ContactJoshua Schulman
CorrespondentJoshua Schulman
MaxQ-Al Ltd. 76 Yigal Alon Street, 5th Floor Tel Aviv,  IL 6706701
Product CodeQAS  
CFR Regulation Number892.2080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-10
Decision Date2018-10-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860001219500 K182177 000

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