FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Eclipse II with Smart Noise Cancellation
K Number: K202441
·
Decision Apr 2, 2021
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
48
Review Days
219
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Basic Information
- Device Name
- Eclipse II with Smart Noise Cancellation
- K Number
- K202441
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carestream Health, Inc.
- Date Received
- August 26, 2020
- Decision Date
- April 2, 2021
- Product Code
- MQB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
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Other Clearances by Carestream Health, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251168 | Image Suite | Sep 4, 2025 | Substantially Equivalent |
| K241505 | DRX-Revolution Mobile X-ray System | Dec 10, 2024 | Substantially Equivalent |
| K233381 | DRX-Evolution Plus System | Mar 12, 2024 | Substantially Equivalent |
| K223842 | DRX - Compass | Jan 20, 2023 | Substantially Equivalent |
| K213307 | Eclipse II with Smart Noise Cancellation | Jan 14, 2022 | Substantially Equivalent |
| K201373 | DRX-Compass | Jun 26, 2020 | Substantially Equivalent |
| K192894 | Vita Flex CR System with LLI | Feb 18, 2020 | Substantially Equivalent |
| K193574 | Q-Rad System | Jan 22, 2020 | Substantially Equivalent |
| K191879 | DRX-Evolution with Carestream Digital Tomosynthesis | Dec 20, 2019 | Substantially Equivalent |
| K190330 | DRX-Evolution/Plus with Dual Energy | Nov 4, 2019 | Substantially Equivalent |