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

Radiological Computer-Assisted Prioritization Software For Lesions

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

QFM is the FDA product code for Radiological Computer-Assisted Prioritization Software For Lesions, a class II device type, regulated under 21 CFR 892.2080. FDA's definition for this code reads: "Radiological computer-assisted prioritization software for lesions 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 41 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QFM
Device name
Radiological Computer-Assisted Prioritization Software For Lesions
FDA definition
Radiological computer-assisted prioritization software for lesions 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
41
Ingested recalls
0

Clearances, product code QFM

By decision year
41 clearances under product code QFM with a decision year between 2019 and 2026, 2022 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code QFM by decision year
YearClearances
20194
20204
20215
20229
20238
20246
20253
20262

Applicants with the most clearances

Product code QFM
Applicants holding the most 510(k) clearances under product code QFM
ApplicantClearances
Aidoc Medical Ltd.5
Zebra Medical Vision, Ltd.5
Annalise-Ai Pty, Ltd.4
Ever Fortune.Ai, Co., Ltd.2
Medcognetics, Inc2
NEUROCAREAI Inc (dba SaveLife.AI)2
Viz. Ai, Inc.2
AZmed1
Avicenna.ai1
Behold.Ai Technologies Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order