Radiology · 510(k) · 2021
Eclipse II with Smart Noise Cancellation
Carestream Health, Inc.. Cleared by FDA on 2 April 2021 under submission K202441, product code MQB (solid state x-ray imager (flat panel/digital imager)). What FDA's record says, in FDA's words.
Device record · K202441
- Device. Eclipse II with Smart Noise CancellationDEVICE
- Company. Carestream Health, Inc.COMPANY
- Decision. 2 April 2021, 510(k), substantially equivalent (traditional review); received 26 August 2020DECISION
- Panel. RadiologyPANEL
- Product code. MQB, Solid State X-Ray Imager (Flat Panel/Digital Imager)CODE
- Regulation. 21 CFR 892.1680, Class IIREG
- Source. FDA database entry · decision document (7 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
same Analysis for and removes grid frequencies from the image. Grid Suppression same Image analysis that identifies the anatomy of interest by detecting direct exposure and collimator blades. Image Segmentation same Optional tech assist features on chest exams that provide auto-orientation (head-up), identify clipped lung bases and provide a CNR image quality metric. Recognition same Automatic determination of rendering parameters based upon features extracted from histograms of the image in support of (4) to (10) frequency bands. Parameter Prediction same Enhanced Noise Reduction Support yesno (4) to (10) frequency bands.Rendering (frequency decomposition and enhancement) same
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1,282 reports filed against devices carrying product code MQB. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
25 September 2026 · Injury · DigitalDiagnost 3.1.x · Philips Medical Systems DMC GmbH · report 3003768251-2026-100038
It was reported that the overhead tube track system was stiff and hard to move while the device was in clinical use. A Good Faith Effort (GFE) was raised to the FSE, and it was clarified that the user sustained an injury to the right dominant shoulder, diagnosed as a shoulder impingement. The user returned to work the following day; however, he is undergoing physical therapy and will be taking time off work to allow for healing, as the injury is aggravated by daily use of the system. […]
24 September 2026 · Injury · DigitalDiagnost C90 HighPerformance · Philips Medical Systems DMC GmbH · report 3003768251-2026-100034
It was reported that the Comfort Positioning feature was not performing as intended while the device was in clinical use. It was further alleged that multiple workers' compensation incidents had occurred as a result of the issue. However, the information currently available is insufficient to adequately assess the reported events. Additional information has been requested from the customer to clarify the allegations and support further investigation and assessment, and a response is currently […]
24 September 2026 · Injury · DigitalDiagnost C90 HighPerformance · Philips Medical Systems DMC GmbH · report 3003768251-2026-100037
It was reported that the Comfort Positioning feature was not performing as intended while the device was in clinical use. It was further alleged that multiple workers' compensation incidents had occurred as a result of the issue. However, the information currently available is insufficient to adequately assess the reported events. Additional information has been requested from the customer to clarify the allegations and support further investigation and assessment, and a response is currently […]
24 September 2026 · Injury · DigitalDiagnost C90 HighPerformance · Philips Medical Systems DMC GmbH · report 3003768251-2026-100035
It was reported that the system did not release efficiently while in use and the customer had to drag the tube head. They also noted that the pulling of the system was also a problem and was severely straining on their shoulders. Additional information has been requested from the customer to clarify the allegations and support further investigation and assessment, and a response is currently pending.
16 September 2026 · Malfunction · DigitalDiagnost C90 Flex/Value/Chest/Emergency Room · Philips Medical Systems DMC GmbH · report 3003768251-2026-100033
It was reported that the Comfort Positioning feature was not performing as intended while the device was in clinical use. A Good Faith Effort (GFE) was initiated which confirmed that only one user was affected by the reported issue. The user, sustained a minor strain to their right (dominant) shoulder and was assessed by their general practitioner, including an ultrasound scan. No further treatment or medical intervention was required. The user has fully recovered, with no expected impact on […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code MQB, in Radiology, from Carestream Health, Inc., or cleared in 2021. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.