8MP COLOR LCD MONITOR, RADIFORCE RX850
FDA 510(k) clearance K140702 · decided 2014-04-04
Clearance details
- K-number
- K140702
- Device name
- 8MP COLOR LCD MONITOR, RADIFORCE RX850
- Applicant
- Eizo Corporation
- Decision
- Substantially Equivalent
- Date received
- 2014-03-20
- Decision date
- 2014-04-04
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- PGY
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hakusan, Ishikawa, JP
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Eizo Corporation
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This p recall (Z-2089-2015) | Eizo Corporation | 2015-07-16 |