Cleared Special

K243548 - BriefCase-Triage

K243548 is an FDA 510(k) clearance for BriefCase-Triage, manufactured by Aidoc Medical , Ltd.. The device is a Class 2 Radiology device with product code QFM cleared through the Special 510(k) pathway after a 26-day FDA review.

K243548 · Aidoc Medical , Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
26d
Days
Class 2
Risk

K243548 is an FDA 510(k) clearance for the BriefCase-Triage. 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 December 11, 2024 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K243548

510(k) Number K243548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2024
Decision Date December 11, 2024
Days to Decision 26 days
Submission Type Special
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
81d faster than avg
Panel avg: 107d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

QFM Device Classification - Class 2, Special Controls

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 40
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K243548 · BriefCase-Triage
Download PDF FDA Summary Aidoc Medical , Ltd.