Radiology · 510(k) · 2023
iCAC Device
Bunkerhill, Inc. Cleared by FDA on 25 April 2023 under submission K230223, product code JAK (system, x-ray, tomography, computed). What FDA's record says, in FDA's words.
Device record · K230223
- Device. iCAC DeviceDEVICE
- Company. Bunkerhill, IncCOMPANY
- Decision. 25 April 2023, 510(k), substantially equivalent (traditional review); received 26 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 (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.
iCAC is a software device intended for use in estimating presence and quantity of coronary artery calcium for patients aged 30 years and above during routine care. The device automatically analyzes non-gated, non-contrast chest computed tomography (CT) images collected during routine care and outputs a visual representation of estimated coronary artery calcium segmentation (intended for informational purposes only) and both exact and four-category quantitative estimates of the patient’s coronary artery calcium burden in Agatston units. The output of the subject device is made available to the physician on-demand as part of his or her standard workflow. The device- generated calcium score or score group can be viewed in the pa tient report at the discretion of the physician, and the physicia n also has the option of viewing the device-generated calcium segmentation in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original chest CT scan; both are still available to be viewed and used at the discretion of the physician. The device is intended to provide information to the physician to provide assistance during review of the patient’s case. Resul ts of the subject device are not intended to be used on a stand-alone basis and are solely intended to aid and provide information to the physician. In all cases, further action taken on a patient should only come at the recommendation of the physician after further reviewing […]
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
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
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, 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.