Eclipse II with Smart Noise Cancellation
by Carestream Health, Inc. 2 variants
510(k) K202441
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK202441 | Date2 Apr 2021 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MQB
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Eclipse II with Smart Noise Cancellation is a Solid State X-Ray Imager (Flat Panel/Digital Imager) designed for digital radiography. It employs advanced image processing to capture high-quality radiographic images while reducing electronic noise, ensuring clear and detailed visualisation of anatomical structures.
This device is integrated into the Carestream ImageView application and operates as a reusable, software-enhanced digital imager. It is intended for use in radiology settings and has received FDA 510(k) clearance under the Radiology advisory committee. The system supports multiple detector sizes and configurations, as listed in the registration numbers, and is regulated under 21 CFR 892.1680. No specific sterility or MRI safety information is provided.