FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Yushan X-Ray Flat Panel Detector with DROC
K Number: K210988
·
Decision Apr 21, 2021
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
6
Review Days
20
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Basic Information
- Device Name
- Yushan X-Ray Flat Panel Detector with DROC
- K Number
- K210988
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innocare Optoelectronics Corp.
- Date Received
- April 1, 2021
- Decision Date
- April 21, 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 Innocare Optoelectronics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K250211 | Yushan X-Ray Flat Panel Detector | Jul 22, 2025 | Substantially Equivalent |
| K243171 | Yushan X-Ray Flat Panel Detector | Dec 19, 2024 | Substantially Equivalent |
| K220510 | Yushan X-Ray Flat Panel Detector with DROC | Apr 14, 2022 | Substantially Equivalent |
| K201528 | Yushan X-Ray Flat Panel Detector with DROC | Oct 11, 2020 | Substantially Equivalent |
| K191939 | Yushan X-Ray Flat Panel Detector | Aug 29, 2019 | Substantially Equivalent |