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
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)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (3)

Bench

sample size not stated

endpoints: analysis of residual image artifacts

Bench

sample size not stated

endpoints: detectability

Reader study (MRMC)

sample size not stated

endpoints: 5-point visual difference preference scale tied to diagnostic confidence; 4-point RadLex scale for 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

2
recalls in product code, 24mo
75
MAUDE reports in code, 12mo
+2%
vs code's own 3-yr baseline
1
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

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Carestream Health Inc.) — same firm and product code, not necessarily this device · initiated 2013-08-29

    Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure

    recall event 66067 (openFDA)

  • Recalling firm matches this device's applicant (Carestream Health, Inc.) — same firm and product code, not necessarily this device · initiated 2012-06-12

    Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns.

    recall event 62310 (openFDA)

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/K202441