Sonio Suspect

K243614

Sonio · cleared 2025-02-21 · product code POK · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.6)

“Sonio Suspect is a Software as a Service (SaaS) solution that aims at helping interpreting physicians (designated as healthcare professionals i.e. HCP in the following) to identify abnormal fetal ultrasound findings during and/or after fetal ultrasound examinations.”

AlgorithmComputer vision Machine Learning-Based Algorithm

source quote (p.9)

“Computer vision Machine Learning-Based Algorithm”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.10)

“Cybersecurity testing”

Validation studies (2)

Bench

n=8,745 images · 75 site(s)

endpoints: sensitivity; specificity

standards: 21 CFR §892.2060 special control 1(iv)

Retrospective clinical

n=750 images · 47 site(s)

endpoints: reader accuracy (AUC)

standards: 21 CFR §892.2060 special control 1(ii), 21 CFR §892.2060 special control 1(iii)

Reported performance (6 observations)

sensitivity0.932CI [91.6%-94.6%]

source quote (p.10)

“The results of the standalone performance testing demonstrated that Sonio Suspect automatically detects abnormal fetal ultrasound findings with a sensitivity of 93.2% (Confidence Interval of [91.6%-94.6%])”

specificity0.908CI [89.5%-92.0%]

source quote (p.10)

“and a specificity of 90.8% (Confidence Interval of [89.5%-92.0%]).”

aurocas written: “auc”0.9

source quote (p.12)

“Particularly, the AUC in the “Unassisted" reading setting is estimated at 68.9%, whilst the AUC in the “Assisted” reading setting is estimated at 90.0% which represents a significant difference of 21.9%, as shown in Figure 1 and Table 4 below.”

sensitivityas written: “Abdominal Situs Inversus Sensitivity”0.993CI (0.976, 1.000)

source quote (p.10)

“The abnormal finding “Abdominal Situs Inversus” has the highest performance in terms of both sensitivity (99.3%)”

specificityas written: “Abdominal Situs Inversus Specificity”0.993CI (0.984, 1.000)

source quote (p.10)

“and specificity (99.3%).”

aurocas written: “Overall AUC Unassisted”0.689CI (0.65, 0.73)

source quote (p.12)

“Particularly, the AUC in the “Unassisted" reading setting is estimated at 68.9%”

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).