Eclipse II with Smart Noise Cancellation
FDA 510(k) K202441 · Carestream Health, Inc.
510(k) numberK202441
Submission
- Device name
- Eclipse II with Smart Noise Cancellation
- Applicant
- Carestream Health, Inc.
Rochester, NY, US - Received
- August 26, 2020
- Decision date
- April 2, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K253800 | 0909FCE, 0909FCE-HSMQB · Traditional | Rayence Co., Ltd. | 07/31/2026SE |
| K260820 | Vivix-S 4386W (FXRD-4386WA)MQB · Special | Vieworks Co., Ltd. | 06/18/2026SE |
| K252996 | Universal 1417PIMQB · Abbreviated | Konica Minolta Healthcare Americas, Inc. | 06/12/2026SE |
| K252911 | Lux HD 2530 detector (Lux HD 2530)MQB · Special | Iray Imaging Technology (Haining) Limited | 10/09/2025SE |
| K250211 | Yushan X-Ray Flat Panel DetectorMQB · Traditional | Innocare Optoelectronics Corp. | 07/22/2025SE |
| K250665 | SKR 3000MQB · Traditional | Konica Minolta, Inc. | 06/17/2025SE |
| K243734 | Wireless/ Wired X-Ray Flat Panel DetectorsMQB · Special | Allengers Medical Systems Limited | 04/18/2025SE |
| K242770 | Expd 114; Expd 114G; Expd 114P; Expd 114PGMQB · Special | DRTECH Corporation | 03/20/2025SE |
| K243443 | Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N…MQB · Special | DRTECH Corporation | 03/19/2025SE |
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)MQB · Traditional | Iray Imaging Technology (Haining) Limited | 03/18/2025SE |
More from Iray Imaging Technology (Haining) Limited
| 510(k) | Device | Decision |
|---|---|---|
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemIZL · Traditional | 03/11/2026SE |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…KPR · Traditional | 01/20/2026SE |
| K251168 | Image SuiteLLZ · Traditional | 09/04/2025SE |
| K241505 | DRX-Revolution Mobile X-ray SystemIZL · Traditional | 12/10/2024SE |
| K233381 | DRX-Evolution Plus SystemKPR · Traditional | 03/12/2024SE |
| K223842 | DRX - CompassKPR · Special | 01/20/2023SE |
| K213568 | DRX-Rise Mobile X-ray SystemIZL · Traditional | 03/23/2022SE |
| K213307 | Eclipse II with Smart Noise CancellationMQB · Traditional | 01/14/2022SE |
| K203159 | Lux 35 DetectorMQB · Special | 12/02/2020SE |
| K201373 | DRX-CompassKPR · Special | 06/26/2020SE |
Questions and answers
When was Eclipse II with Smart Noise Cancellation cleared by the FDA?
Eclipse II with Smart Noise Cancellation (K202441) received a 510(k) decision of Substantially Equivalent on April 2, 2021, 219 days after the submission was received.
What is the product code of K202441?
The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.