LungVision

K240943

BodyVision Medical Ltd. · cleared 2024-10-01 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.5)

“The LungVision system includes a main unit and a tablet. Image processing algorithms are executed on the main unit and the tablet is used as a primary method of interacting with the system. LungVision includes hardware and complies with ANSI/AAMI/ES 60601-1:2005(2012) and IEC 60601-1-2:2014. AI-driven intraoperative tomographic imaging”

AlgorithmAI-driven intraoperative tomographic imaging; limited angle tomography based on the SIRT algorithm

source quote (p.5)

“AI-driven intraoperative tomographic imaging. CABT is a limited angle tomography based on the SIRT algorithm”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (5)

Bench

sample size not stated

Bench

sample size not stated

Bench

n=500 cases

endpoints: mean accuracy

Bench

n=93 cases

endpoints: mean accuracy

Retrospective clinical

n=191 cases · 3 site(s)

endpoints: mean accuracy; lesion marking accuracy

Reported performance (3 observations)

accuracyas written: “mean accuracy”3.15CI 3.2 mm std

source quote (p.8)

“The mean accuracy calculated for 500 cases is 3.15 mm with 3.2 mm std.”

accuracyas written: “mean accuracy”3.64CI 1.57 mm std

source quote (p.8)

“The mean accuracy calculated for 93 cases is 3.64 mm with 1.57 mm std.”

accuracyas written: “mean accuracy”5.34CI 3.32 mm std

source quote (p.8)

“The mean accuracy calculated for 191 cases is 5.34 mm with 3.32 mm std”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

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).