Radiology · 510(k) · 2020
InferRead Lung CT.AI
Beijing Infervision Technology Co.,Ltd.. Cleared by FDA on 2 July 2020 under submission K192880, product code OEB (lung computed tomography system, computer-aided detection). What FDA's record says, in FDA's words.
Device record · K192880
- Device. InferRead Lung CT.AIDEVICE
- Company. Beijing Infervision Technology Co.,Ltd. (CN)COMPANY
- Decision. 2 July 2020, 510(k), substantially equivalent (traditional review); received 9 October 2019DECISION
- 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 (10 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.
lnferRead Lung CT.AI is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest on an asymptomatic population. Infer Read Lung CT.AI requires that both lungs be in the field of view. lnferRead Lung CT.AI provides adjunctive information and is not intended to be used without 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
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 2020. 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.