Auto Segmentation

K230082

GE Medical Systems, LLC · cleared 2023-05-04 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“Auto Segmentation is a post-processing software designed to automatically generate contours of organ(s) at risk (OARs) from Computed Tomography (CT) images in the form of a DICOM Radiotherapy Structure Set (RTSS) series.”

Algorithmdeep learning algorithms

source quote (p.5)

“Auto Segmentation uses deep learning algorithms to generate organ at risk contours for the head and neck, thorax, abdomen and pelvis regions from CT images across 40 organ(s) or organ subregion(s).”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=302 patients

endpoints: DICE similarity coefficient (DSC)

standards: ISO 13485

Reader study (MRMC)

sample size not stated

endpoints: adequacy of the subject device generated contours (Likert scale)

Reported performance (40 observations)

diceas written: “Dice Mean (Adrenal Left)”0.7868CI 76.63%

source quote (p.8)

“Adrenal Left 78.68% 76.63%”

diceas written: “Dice Mean (Adrenal Right)”0.7248CI 69.78%

source quote (p.8)

“Adrenal Right 72.48% 69.78%”

diceas written: “Dice Mean (Bladder)”0.815CI 78.33%

source quote (p.8)

“Bladder 81.50% 78.33%”

diceas written: “Dice Mean (Body)”0.995CI 99.38%

source quote (p.8)

“Body 99.50% 99.38%”

diceas written: “Dice Mean (Brainstem)”0.8769CI 87.15%

source quote (p.8)

“Brainstem 87.69% 87.15%”

diceas written: “Dice Mean (Chiasma)”0.4381CI 41.03%

source quote (p.8)

“Chiasma 43.81% 41.03%”

diceas written: “Dice Mean (Esophagus)”0.8169CI 80.38%

source quote (p.8)

“Esophagus 81.69% 80.38%”

diceas written: “Dice Mean (Eye Left)”0.9132CI 89.77%

source quote (p.8)

“Eye Left 91.32% 89.77%”

diceas written: “Dice Mean (Eye Right)”0.9025CI 88.23%

source quote (p.8)

“Eye Right 90.25% 88.23%”

diceas written: “Dice Mean (Femur Left)”0.9765CI 97.18%

source quote (p.8)

“Femur Left 97.65% 97.18%”

diceas written: “Dice Mean (Femur Right)”0.9792CI 97.78%

source quote (p.8)

“Femur Right 97.92% 97.78%”

diceas written: “Dice Mean (Kidney Left)”0.9253CI 90.30%

source quote (p.8)

“Kidney Left 92.53% 90.30%”

diceas written: “Dice Mean (Kidney Right)”0.9482CI 93.48%

source quote (p.8)

“Kidney Right 94.82% 93.48%”

diceas written: “Dice Mean (Lacrimal Gland Left)”0.5979CI 57.65%

source quote (p.8)

“Lacrimal Gland Left 59.79% 57.65%”

diceas written: “Dice Mean (Lacrimal Gland Right)”0.5809CI 55.81%

source quote (p.8)

“Lacrimal Gland Right 58.09% 55.81%”

diceas written: “Dice Mean (Lens Left)”0.7686CI 74.80%

source quote (p.8)

“Lens Left 76.86% 74.80%”

diceas written: “Dice Mean (Lens Right)”0.7909CI 77.40%

source quote (p.8)

“Lens Right 79.09% 77.40%”

diceas written: “Dice Mean (Liver)”0.9428CI 92.27%

source quote (p.8)

“Liver 94.28% 92.27%”

diceas written: “Dice Mean (Lung Left)”0.977CI 97.38%

source quote (p.8)

“Lung Left 97.70% 97.38%”

diceas written: “Dice Mean (Lung Right)”0.9799CI 97.81%

source quote (p.8)

“Lung Right 97.99% 97.81%”

diceas written: “Dice Mean (Mandible)”0.927CI 92.36%

source quote (p.8)

“Mandible 92.70% 92.36%”

diceas written: “Dice Mean (Optic Nerve Left)”0.7922CI 77.99%

source quote (p.9)

“Optic Nerve Left 79.22% 77.99%”

diceas written: “Dice Mean (Optic Nerve Right)”0.802CI 78.94%

source quote (p.9)

“Optic Nerve Right 80.20% 78.94%”

diceas written: “Dice Mean (Oral Cavity)”0.8743CI 86.20%

source quote (p.9)

“Oral Cavity 87.43% 86.20%”

diceas written: “Dice Mean (Pancreas)”0.8034CI 78.50%

source quote (p.9)

“Pancreas 80.34% 78.50%”

diceas written: “Dice Mean (Parotid Left)”0.8435CI 83.27%

source quote (p.9)

“Parotid Left 84.35% 83.27%”

diceas written: “Dice Mean (Parotid Right)”0.8555CI 84.48%

source quote (p.9)

“Parotid Right 85.55% 84.48%”

diceas written: “Dice Mean (Proximal Bronchial Tree (PBtree))”0.8494CI 83.71%

source quote (p.9)

“Proximal Bronchial Tree (PBtree) 84.94% 83.71%”

diceas written: “Dice Mean (Inferior PCM (Pharyngeal Constrictor Muscle))”0.7051CI 68.72%

source quote (p.9)

“Inferior PCM (Pharyngeal Constrictor Muscle) 70.51% 68.72%”

diceas written: “Dice Mean (Middle PCM)”0.6709CI 65.21%

source quote (p.9)

“Middle PCM 67.09% 65.21%”

diceas written: “Dice Mean (Superior PCM)”0.5957CI 57.85%

source quote (p.9)

“Superior PCM 59.57% 57.85%”

diceas written: “Dice Mean (Pericardium)”0.9358CI 92.00%

source quote (p.9)

“Pericardium 93.58% 92.00%”

diceas written: “Dice Mean (Pituitary)”0.7562CI 74.12%

source quote (p.9)

“Pituitary 75.62% 74.12%”

diceas written: “Dice Mean (Prostate)”0.7967CI 77.60%

source quote (p.9)

“Prostate 79.67% 77.60%”

diceas written: “Dice Mean (Spinal Cord)”0.8855CI 87.43%

source quote (p.9)

“Spinal Cord 88.55% 87.43%”

diceas written: “Dice Mean (Submandibular Left)”0.8685CI 85.95%

source quote (p.9)

“Submandibular Left 86.85% 85.95%”

diceas written: “Dice Mean (Submandibular Right)”0.857CI 84.79%

source quote (p.9)

“Submandibular Right 85.70% 84.79%”

diceas written: “Dice Mean (Thyroid)”0.8537CI 84.27%

source quote (p.9)

“Thyroid 85.37% 84.27%”

diceas written: “Dice Mean (Trachea)”0.9102CI 90.47%

source quote (p.9)

“Trachea 91.02% 90.47%”

diceas written: “Dice Mean (Whole Brain)”0.9853CI 98.46%

source quote (p.9)

“Whole Brain 98.53% 98.46%”

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).