Radiology · 510(k) · 2023
AVIEW Lung Nodule CAD
Coreline Soft Co.,Ltd.. Cleared by FDA on 24 February 2023 under submission K221592, product code OEB (lung computed tomography system, computer-aided detection). What FDA's record says, in FDA's words.
Device record · K221592
- Device. AVIEW Lung Nodule CADDEVICE
- Company. Coreline Soft Co.,Ltd. (KR)COMPANY
- Decision. 24 February 2023, 510(k), substantially equivalent (traditional review); received 2 June 2022DECISION
- 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 (12 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.
A VIEW Lung Nodule CAD is a Computer -Aided Detection (CAD) software designed to assist radiologists in the detection of pulmonary nodules (with diameter 3 -20 mm) during the review of CT examinations of the chest for asymptomatic populations. A VIEW Lung Nodule CAD provides adjunctive information to alert the radiologists to regions of interest with suspected lung nodules that may otherwise be overlooked. A VIEW Lung Nodule CAD may be used as a second reader after the ra diologist has completed their initial read. The algorithm has been validated using non-contrast CT images, the majority of which were acquired on Siemens SOMA TOM CT series scanners; therefore, limiting device use to use with Siemens SOMATOM CT series is recommended. 7 COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE A VIEW Lung Nodule CAD has the same intended use and the principle of operation and has similar features to the predicate devices. Snygo.CT Lung CAD (VD20) (K203258). There m ight be slight differences in features and menu, but these differences between the predicate device and the proposed device are not so significant since they do not raise any new or potential safety risks to the user or patient and questions of safety or effectiveness. Based on the results of software validation and verification tests, we conclude that the proposed device is substantially equivalent to the predicate devices. 3 Characteristic Subject Device Predicate Device Reference Device Reference […]
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
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, from Coreline Soft Co.,Ltd., or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
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