Radiology · 510(k) · 2021
syngo.CT Lung CAD
Siemens Healthcare GmbH. Cleared by FDA on 31 March 2021 under submission K203258, product code OEB (lung computed tomography system, computer-aided detection). What FDA's record says, in FDA's words.
Device record · K203258
- Device. syngo.CT Lung CADDEVICE
- Company. Siemens Healthcare GmbH (DE)COMPANY
- Decision. 31 March 2021, 510(k), substantially equivalent (traditional review); received 5 November 2020DECISION
- 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 (17 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.
The syngo.CT Lung CAD device is a Computer-Aided Detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid (part-solid and ground glass) pulmonary nodules during review of multi-detector computed tomography (MDCT) from multivendor examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may otherwise be overlooked. The syngo.CT Lung CAD device may be used as a concurrent first reader followed by a full review of the case by the radiologist or as second reader after the radiologist has completed his/her initial read. The software device is an algorithm which does not have its own user interface component for displaying of CAD marks. The Hosting Application incorporating syngo.CT Lung CAD is responsible for implementing a user interface.
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 Siemens Healthcare GmbH, or cleared in 2021. The whole record is at FDA AI-enabled medical devices.
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