Device
CAC (gated) is a software device intended for use in estimating presence and quantity of coronary artery calcium for patients aged 30 years and above. The device automatically anal...
Manufacturer
Bunkerhill Health Inc.
Bunkerhill Health Inc.
Model: 1
DI: 00860015781901
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Description
CAC (gated) is a software device intended for use in estimating presence and quantity of coronary artery calcium for patients aged 30 years and above. The device automatically analyzes non contrast electrocardiogram (ECG) gated cardiac computed tomography (CT) images collected and outputs the segmentation (intended for informational purposes only) and quantification of detected calcium.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ed5100f7-6e73-44df-9bf1-2e6a02b7332f
Distribution Status:
In Commercial Distribution
DUNS Number:
117220923
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860015781901
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 63386
Name: X-ray image interpretive software
Definition:
An interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].
FDA Product Codes
JAK
System, X-Ray, Tomography, Computed
Premarket Submissions
Submission Number:
K240369
Supplement Number:
000