510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QASClass II

Radiological Computer-Assisted Triage And Notification Software

21 CFR 892.2080 / Radiology
FDA source (opens on fda.gov)

QAS is the FDA product code for Radiological Computer-Assisted Triage And Notification Software, a class II device type, regulated under 21 CFR 892.2080. FDA's definition for this code reads: "Radiological computer-assisted triage and notification software is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or...". As of , FDA records hold 87 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QAS
Device name
Radiological Computer-Assisted Triage And Notification Software
FDA definition
Radiological computer-assisted triage and notification software is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification .
Regulation
21 CFR 892.2080
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
88
Ingested recalls
0

Clearances, product code QAS

By decision year
88 clearances under product code QAS with a decision year between 2018 and 2026, 2022 the highest year at 15.
Show the numbers
510(k) clearances under FDA product code QAS by decision year
YearClearances
20183
20195
202012
20215
202215
202311
202412
202515
202610

Applicants with the most clearances

Product code QAS
Applicants holding the most 510(k) clearances under product code QAS
ApplicantClearances
Aidoc Medical Ltd.25
Ischemaview, Inc.9
Avicenna.ai5
Ever Fortune.Ai, Co., Ltd.5
Annalise-Ai Pty, Ltd.4
Brainomix Limited4
JLK, Inc.4
Viz. Ai, Inc.4
Siemens Medical Solutions USA, Inc.3
Maxq AL, Ltd.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order