LungVision

K240943

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

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Automated radiological image processing software QIH, CFR 892.2050 Picture archiving and communications system LLZ, CFR 892.2050 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)No
PCCPNo
Cybersecurity addressedNo

Validation studies (4)

Bench

sample size not stated

Standalone

n=500 cases

endpoints: registration error

Standalone

n=93 cases

endpoints: accuracy

Retrospective clinical

n=191 cases

endpoints: lesion marking accuracy; accuracy of the registration process

standards: ANSI/AAMI/ES 60601-1:2005(2012), IEC 60601-1-2:2014

Reported performance (3 observations)

accuracyas written: “mean accuracy (Simulated cases)”3.15
source quote (p.8)
“The mean accuracy calculated for 500 cases is 3.15 mm with 3.2 mm std.”
accuracyas written: “mean accuracy (Rigid body model cases)”3.64
source quote (p.8)
“The mean accuracy calculated for 93 cases is 3.64 mm with 1.57 mm std.”
accuracyas written: “mean accuracy (CBCT scans cases)”5.34
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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K240943