FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
2MP Color LCD Monitor, RadiForce RX250 and RX250-AR
K Number: K160247
·
Decision Feb 23, 2016
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
134
Applicant Total
29
Review Days
22
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- 2MP Color LCD Monitor, RadiForce RX250 and RX250-AR
- K Number
- K160247
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eizo Corporation
- Date Received
- February 1, 2016
- Decision Date
- February 23, 2016
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PGY), ordered by most recent decision date.
Medical Monitor (40HT513D)
FDA 510(k)
FDA Class 2
·Radiology
LCD Monitor (CL1902A, CL2103F)
FDA 510(k)
FDA Class 2
·Radiology
LCD Monitor (C1216W, C822W, C821W)
FDA 510(k)
FDA Class 2
·Radiology
RadiForce GX570; RadiForce GX570-AR
FDA 510(k)
FDA Class 2
·Radiology
RadiForce RX570; RadiForce RX570-AR
FDA 510(k)
FDA Class 2
·Radiology
LCD Monitors C310S, G310S, C316S, G316S, C616W
FDA 510(k)
FDA Class 2
·Radiology
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 |
| K243221 | RadiForce RX570; RadiForce RX570-AR | Nov 27, 2024 | 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 |