Radiology · 510(k) · 2022
AI-Rad Companion (Pulmonary)
Siemens Healthcare GmBh. Cleared by FDA on 11 August 2022 under submission K213713, product code JAK (system, x-ray, tomography, computed). What FDA's record says, in FDA's words.
Device record · K213713
- Device. AI-Rad Companion (Pulmonary)DEVICE
- Company. Siemens Healthcare GmBhCOMPANY
- Decision. 11 August 2022, 510(k), substantially equivalent (traditional review); received 24 November 2021DECISION
- Panel. RadiologyPANEL
- Product code. JAK, System, X-Ray, Tomography, ComputedCODE
- Regulation. 21 CFR 892.1750, 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.
AI-Rad Companion (Pulmonary) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of disease of the lungs. It provides the following functionality: • Segmentation and measurements of complete lung and lung lobes • Identification of areas with lower Hounsfield values in comparison to a predefined threshold for complete lung and lung lobes • Providing an interface to external Medical Device syngo.CT Lung CAD • Segmentation and measurements of solid lung nodules • Dedication of found lung nodules to corresponding lung lobe • Correlation of segmented lung nodules of current scan with known priors and quantitative assessment of changes of the correlated data. • Identification of areas with elevated Hounsfield values, where areas with elevated versus high opacities are distinguished. The software has been validated for data from Siemens Healthineers (filtered backprojection and iterative reconstruction), GE Healthcare (filtered backprojection reconstruction), and Philips (filtered backprojection reconstruction). Only DI COM images of adult patients are considered to be valid input.
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
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 5,281 reports filed against devices carrying product code JAK. 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. The latest reports, in the reporter’s words:
25 September 2026 · Malfunction · REVOLUTION EVO · GE MEDICAL SYSTEMS, LLC · report 50896044
The GE CT table wouldn't move during stroke. Patient had to be physically moved to resume scan, delay in care. GE CT table has had the same issues with the table working intermittently x 3 weeks. Multiple techs have worked on it and the same problem persists.
25 September 2026 · Malfunction · Needle Guide · Quantum Surgical SAS · report 3023140882-2026-00002
23 September 2026 · Malfunction · ILLUMISITE · COVIDIEN LP - SUPERDIMENSION INC · report 3004962788-2026-00087
It was reported that during the procedure, one locatable guide indicated as outside of the sensor sensing volume and another locatable guide had difficulty retracting from the extended working channel. The physician completed the superDimension portion of the case. No patient complications have been reported as a result of this event.
23 September 2026 · Other · NL4000 · Samsung HME America, Inc. · report 3004938766-2026-00043
23 September 2026 · Malfunction · ILLUMISITE · COVIDIEN LP - SUPERDIMENSION INC · report 3004962788-2026-00088
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 JAK, in Radiology, from Siemens Healthcare GmBh, or cleared in 2022. 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.