Eclipse II with Smart Noise Cancellation

K202441

Carestream Health, Inc. · cleared 2021-04-02 · product code MQB · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“The software performs digital enhancement of a radiographic image generated by an x-ray device.”

AlgorithmConvolutional Neural Network (CNN) based on a U-Net architecture, trained using clinical images with added simulated noise to represent reduced signal-to-noise acquisitions for noise suppression.

source quote (p.5)

“The Smart Noise Cancellation module consists of a Convolutional Neural Network (CNN) trained using clinical images with added simulated noise to represent reduced signal-to-noise acquisitions. The Smart Noise Cancellation operation passes the acquired preprocessed image through a specially trained Convolutional Neural Network (CNN) based on a U-Net architecture to generate a 2D map of the estimated noise found in the image, identified in the document as a "Noise Field."”

Adaptive (vs locked)No

source quote (p.5)

“The Smart Noise Cancellation module consists of a Convolutional Neural Network (CNN) trained using clinical images with added simulated noise to represent reduced signal-to-noise acquisitions.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (3)

Bench

sample size not stated

endpoints: residual image artifacts

Bench

sample size not stated

endpoints: detectability

Reader study (MRMC)

sample size not stated

endpoints: diagnostic confidence; overall diagnostic capability

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

+2%

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K213307 (decision 2022-01-14) from Carestream Health, Inc. for a matching device line ("Eclipse II with Smart Noise Cancellation") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K213307

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).