CogNet QmTRIAGE
FDA 510(k) K220080 · Medcognetics, Inc.
510(k) numberK220080
Submission
- Device name
- CogNet QmTRIAGE
- Applicant
- Medcognetics, Inc.
Dallas, TX, US - Received
- January 10, 2022
- Decision date
- September 29, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QFM – Radiological Computer-Assisted Prioritization Software For Lesions
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2080
- Specialty
- Radiology
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…
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More from Milvue
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|---|---|---|
| K252482 | CogNet AI-MT+QFM · Traditional | 12/11/2025SE |
Questions and answers
When was CogNet QmTRIAGE cleared by the FDA?
CogNet QmTRIAGE (K220080) received a 510(k) decision of Substantially Equivalent on September 29, 2022, 262 days after the submission was received.
What is the product code of K220080?
The FDA product code is QFM – Radiological Computer-Assisted Prioritization Software For Lesions, a Class II (moderate risk) device regulated under 21 CFR 892.2080.