K223768 is an FDA 510(k) clearance for the RadiForce RX270. This device is classified as a Display, Diagnostic Radiology (Class II - Special Controls, product code PGY).
Submitted by Eizo Corporation (Hakusan, JP). The FDA issued a Cleared decision on April 20, 2023, 126 days after receiving the submission on December 15, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050. The Device Is Intended For Use In Displaying Radiological Images For Review, Analysis, And Diagnosis By Trained Medical Practitioners..
| 510(k) Number | K223768 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2022 |
| Decision Date | April 20, 2023 |
| Days to Decision | 126 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | PGY — Display, Diagnostic Radiology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |
| Definition | The Device Is Intended For Use In Displaying Radiological Images For Review, Analysis, And Diagnosis By Trained Medical Practitioners. |