Eclipse II with Smart Noise Cancellation is an AI-enabled medical device from Carestream Health, Inc. that the U.S. FDA cleared through 510(k) K213307 on January 14, 2022. Its lead review panel is Radiology and its primary product code is MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)).
See also FDA-cleared AI radiology devices in 2022, all FDA AI clearances in 2022, top radiology AI devices.
Key facts
| Submission number | K213307 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Carestream Health, Inc. |
| Lead review panel | Radiology |
| Primary product code | MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Applicant (openFDA) | Carestream Health, Inc. |
| Applicant location | Rochester, NY, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 892.1680 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Eclipse II with Smart Noise Cancellation went through this pathway (K213307).
openFDA lists it as a Class 2 device under 21 CFR 892.1680. Class II devices are moderate risk and are subject to general and special controls.
Product code MQB covers 3 devices on the FDA AI list. By decision date, this device is #3 of 3 under that code. Carestream Health, Inc. has 2 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.
Similar devices (product code MQB)
- Intelligent NRCanon Inc. · Radiology
- Eclipse II with Smart Noise CancellationCarestream Health, Inc. · Radiology