Imbio PHA (4.0.0)

K241847

Imbio, Inc · cleared 2024-08-30 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Imbio PHA Software is a Software as a Medical Device (SaMD) intended to provide annotated DICOM-formatted images and a PDF report that will be read most typically at a PACS workstation.”
Algorithmmedical image post-processing computer algorithms, artificial intelligence algorithm, deep-learning models for segmentation and measurement
source quote (p.5)
“Imbio's PHA Software is a set of medical image post-processing computer algorithms that together perform automated right and left ventricle, pulmonary artery (PA), and aorta (Ao) measurements from CT pulmonary angiography (CTPA) scans, and reports the RV/LV and PA/Ao ratios. PHA analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the anatomy. The overall intended use of the devices are equivalent: to use deep-learning models to measure diameters of clinically relevant cardiovascular structures from a CTPA image. LV Segmentation: Yes - Deep Learning, RV Segmentation: Yes - Deep Learning, mPA Segmentation: Yes - Deep Learning, Ao Segmentation: Yes - Deep Learning”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Reader study (MRMC)

n=100 cases

endpoints: Intra-class correlation coefficients were calculated to show equivalency.; ICC of all measurements (annotators and algorithm) > 0.90 (excellent); ICC of all measurements (annotators and algorithm) within 95% CI of the ICC of only annotators

Reported performance (1 observation)

agreement_kappaas written: “ICC”0.94
source quote (p.7)
“The ICC between three expert radiologists and the algorithm results is 0.94, indicating excellent agreement.”

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/K241847