Radiology · 510(k) · 2019
AI-Rad Companion (Cardiovascular)
Siemens Medical Solutions USA, Inc.. Cleared by FDA on 10 September 2019 under submission K183268, product code JAK (system, x-ray, tomography, computed). What FDA's record says, in FDA's words.
Device record · K183268
- Device. AI-Rad Companion (Cardiovascular)DEVICE
- Company. Siemens Medical Solutions USA, Inc.COMPANY
- Decision. 10 September 2019, 510(k), substantially equivalent (traditional review); received 23 November 2018DECISION
- Panel. RadiologyPANEL
- Product code. JAK, System, X-Ray, Tomography, ComputedCODE
- Regulation. 21 CFR 892.1750, Class IIREG
- Source. FDA database entry · decision document (9 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 (Cardiovascular) 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 cardiovascular diseases. It provides the following functionality: • Segmentation and volume measurement of the heart • Quantification of the total calcium volume in the coronary arteries • Segmentation of the aorta • Measurement of maximum diameters of the aorta at typical landmarks • Threshold-based highlighting of enlarged diameters The software has been validated for non-cardiac chest CT data with filtered backprojection reconstruction from Siemens Healthineers, GE Healthcare, Philips, and Toshiba/Canon. Additionally, the calcium detection feature has been validated on non-cardiac chest CT data with iterative reconstruction from Siemens Healthineers. Only DICOM 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 Medical Solutions USA, Inc., or cleared in 2019. 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.