Cleared Traditional

K214043 - BriefCase (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K214043 · Aidoc Medical , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
81d
Days
Class 2
Risk

K214043 is an FDA 510(k) clearance for the BriefCase. Classified as Radiological Computer-assisted Prioritization Software For Lesions (product code QFM), Class II - Special Controls.

Submitted by Aidoc Medical , Ltd. (Tell-Aviv, IL). The FDA issued a Cleared decision on March 14, 2022 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2080 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aidoc Medical , Ltd. devices

Submission Details

510(k) Number K214043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2021
Decision Date March 14, 2022
Days to Decision 81 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 107d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QFM Radiological Computer-assisted Prioritization Software For Lesions
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2080
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
John J. Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QFM Radiological Computer-assisted Prioritization Software For Lesions

All 38
Devices cleared under the same product code (QFM) and FDA review panel - the closest regulatory comparables to K214043.
CogNet AI-MT+
K252482 · Medcognetics, Inc. · Dec 2025
Annalise Enterprise
K250831 · Annalise-Ai · Apr 2025
Rayvolve PTX-PE
K243808 · AZmed · Mar 2025
BriefCase-Triage
K243548 · Aidoc Medical , Ltd. · Dec 2024
VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
K241439 · Vuno, Inc. · Nov 2024
CINA-VCF
K240612 · Avicenna.Ai · May 2024