Eclipse II with Smart Noise Cancellation

K213307

Carestream Health, Inc. · cleared 2022-01-14 · product code MQB · Radiology

Premarket evidence — what FDA accepted

Device typesimd
source quote (p.4)
“Eclipse software runs inside the ImageView product application software (not considered stand-alone software).”
AlgorithmConvolutional Neural Network (CNN) based on a U-Net architecture
source quote (p.4)
“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
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Reader study (MRMC)

sample size not stated

endpoints: 5-point visual difference preference scale (-2 to +2) tied to diagnostic confidence; 4-point RadLexscale

standards: ISO 14971, FDA “Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices"

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
0
drift signals on this device

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/K213307