Radiology · 510(k) · 2025
V5med Lung AI
V5med Inc.. Cleared by FDA on 27 March 2025 under submission K242919, product code OEB (lung computed tomography system, computer-aided detection). What FDA's record says, in FDA's words.
Device record · K242919
- Device. V5med Lung AIDEVICE
- Company. V5med Inc. (TW)COMPANY
- Decision. 27 March 2025, 510(k), substantially equivalent (traditional review); received 24 September 2024DECISION
- Panel. RadiologyPANEL
- Product code. OEB, Lung Computed Tomography System, Computer-Aided DetectionCODE
- Regulation. 21 CFR 892.2050, Class IIREG
- Source. FDA database entry · decision document (11 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
V5med Lung Al is a Computer-Aided Detection (CAD) software designed to assist radiologists in detecting pulmonary nodules (with diameter of 4-30 mm) during CT examinations of the chest for asymptomatic populations. This software provides adjunctive information to alert radiologists to regions of interest with suspected lung nodules that may otherwise be overlooked. It can be used in a concurrent read mode, where the Al analysis results are displayed alongside the original CT images during either the initial review or any subsequent reviews by the radiologist. V5med Lung Al does not replace the radiologist's critical judgment or diagnostic processes and should not be used in isolation from the original CT series.
The product code's definition, from FDA's classification record. To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review. A computer aided diagnosis, lung computed tomography system is a class 3 device under product code NRR.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code OEB. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code OEB, in Radiology, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.