FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
RadiForce RX570; RadiForce RX570-AR
K Number: K243221
·
Decision Nov 27, 2024
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
134
Applicant Total
29
Review Days
51
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Basic Information
- Device Name
- RadiForce RX570; RadiForce RX570-AR
- K Number
- K243221
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eizo Corporation
- Date Received
- October 7, 2024
- Decision Date
- November 27, 2024
- Product Code
- PGY
- 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 |
|---|---|---|---|
| PGY | Display, Diagnostic Radiology | FDA class 2 | Radiology |
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Other Clearances by Eizo Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K252030 | RadiForce GX570; RadiForce GX570-AR | Aug 28, 2025 | Substantially Equivalent |
| K242545 | RadiForce MX317W-PA | May 23, 2025 | Substantially Equivalent |
| K241441 | RadiForce RX670; RadiForce RX670-AR | Jul 16, 2024 | Substantially Equivalent |
| K233465 | RadiForce MX317W | Dec 21, 2023 | Substantially Equivalent |
| K231066 | CuratOR EX3242-FD | Dec 18, 2023 | Substantially Equivalent |
| K230684 | RadiForce MX217 | May 12, 2023 | Substantially Equivalent |
| K223768 | RadiForce RX270 | Apr 20, 2023 | Substantially Equivalent |
| K221136 | RadiForce MX243W | May 10, 2022 | Substantially Equivalent |
| K211491 | RadiForce RX370 | Jul 12, 2021 | Substantially Equivalent |
| K200485 | RadiForce RX1270, RadiForce RX1270-AR | Mar 23, 2020 | Substantially Equivalent |