Radiology · 510(k) · 2023
CAC Software
Imbio, Inc.. Cleared by FDA on 13 June 2023 under submission K230112, product code JAK (system, x-ray, tomography, computed). What FDA's record says, in FDA's words.
Device record · K230112
- Device. CAC SoftwareDEVICE
- Company. Imbio, Inc.COMPANY
- Decision. 13 June 2023, 510(k), substantially equivalent (traditional review); received 17 January 2023DECISION
- 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.
Imbio CAC Software is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. Imbio CAC Software uses machine learning to analyze non-contrast thoracic CT images and outputs a summary report containing Agatston score, arterial age, and calcified lesion mass and volume metrics of the calcification burden for the whole heart and individual coronary artery level. Additionally, Imbio CAC Software outputs annotated images previewing the segmentation of calcifications for informational purposes only. Imbio CAC Software is limited to the quantification of detected possible calcifications in adult patients ≥ 29 years of age. It does not diagnose coronary artery disease. The device output will be available to the users as part of the standard DICOM viewing workflow. The Imbio CAC Software results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CT images.
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 Imbio, Inc., or cleared in 2023. 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.