DeepCT

K182875

Deep01 Limited · cleared 2019-07-10 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
DeepCT (Ver. 4.1.4) is a software-only device that uses two components: (1) Image Forwarding Software and (2) Image Processing and Analysis Server. DeepCT uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified clinical condition
AlgorithmA deep residual convolutional neural network (aka Residual Network or ResNet for short) was adopted as the core learning model. The ResNet model can ease the training of networks that are substantially deeper, effectively help the convergence of the model and gain the accuracy with deep neural networks. The model was trained with a categorical cross-entropy loss with Adam optimizer. Data augmentation was introduced. The system was trained with PyTorch. A 34-layer Residual Network was chosen as the final model.
source quote (p.6)
A deep residual convolutional neural network (aka Residual Network or ResNet for short, see Kaiming He et al. https://arxiv.org/abs/1512.03385) was adopted as the core learning model. By repeatedly applying residual connection, the ResNet model can ease the training of networks that are substantially deeper, effectively help the convergence of the model and gain the accuracy with deep neural networks. The model was trained with a categorical cross-entropy loss with Adam optimizer. Data augmentation was introduced to motivate the model to learn the rotated and translated images. Our DeepCT system was trained with PyTorch, an open source deep learning software library (https://pytorch.org). Same model with three different layer size, 18, 34, 52, respectively, were trained to cross evaluate the model performance. 34-layer Residual Network was chose as the final model since it got the best tradeoff between performance and computation complexity. We saw little performance gain by extending from 34 to 52 layers.
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=260 cases · 5 site(s)

endpoints: evaluate the software's performance in identifying non-contrast CT head images containing ICH findings

Reported performance (2 observations)

sensitivity0.938CI 88.3%-96.8%
source quote (p.9)
Specifically, sensitivity was observed to be 93.8% (95% CI: 88.3%-96.8%) and specificity was observed to be 92.3% (95% CI: 86.4%-95.7%).
specificity0.923CI 86.4%-95.7%
source quote (p.9)
Specifically, sensitivity was observed to be 93.8% (95% CI: 88.3%-96.8%) and specificity was observed to be 92.3% (95% CI: 86.4%-95.7%).

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
0
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). 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).

RIGOR™ Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: radar.healthai.com/precedent/device/K182875