Bunkerhill Contrast CAC
K260166BunkerHill Health · cleared 2026-03-06 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“Bunkerhill Contrast CAC is a software as a medical device (SaMD) product that interfaces with compatible and commercially available computed tomography (CT) systems.”
source quote (p.8)
“Both the predicate(s) and the subject device use deep-learning algorithms to identify the presence of calcification and estimate calcification.”
source quote (p.11)
“Safety and performance of Bunkerhill Contrast CAC has been evaluated and verified in accordance with software specifications and applicable performance standards through Software Development and Validation & Verification Process to ensure performance according to specifications, User Requirements and Federal Regulations and Guidance documents, “Content of Premarket Submissions for Device Software Functions” and Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.”
Validation studies (2)
Retrospective clinical
sample size not stated
endpoints: Sensitivity; Specificity; Precision; Recall of the circular ROI; correlation coefficient; Bland Altman agreement
Standalone
n=50 cases
endpoints: mean bias; LOA
Reported performance (4 observations)
source quote (p.11)
“The observed Sensitivity 0.957 (0.924, 0.991), the observed Specificity was 0.929 (0.882, 0.976), the observed Precision was 0.814 (0.776, 0.850) and the observed Recall was 0.755 (0.712, 0.797).”
source quote (p.11)
“The observed Sensitivity 0.957 (0.924, 0.991), the observed Specificity was 0.929 (0.882, 0.976), the observed Precision was 0.814 (0.776, 0.850) and the observed Recall was 0.755 (0.712, 0.797).”
source quote (p.11)
“the observed Precision was 0.814 (0.776, 0.850)”
source quote (p.11)
“the observed Recall was 0.755 (0.712, 0.797)”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (GE Medical Systems, LLC, initiated 2026-03-26): "GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98738
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2026-03-07): "Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98588
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (Siemens Medical Solutions USA, Inc, initiated 2025-12-19): "To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98206
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2025-09-25): "Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axia" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97699
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (Philips North America Llc, initiated 2025-05-29): "Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97010
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (, initiated 2025-05-23): "Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:96967
- …and 3 more.
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).