Definition: The Device Is Intended For Use In Displaying Radiological Images For Review, Analysis, And Diagnosis By Trained Medical Practitioners.
| Device Type ID | 5423 |
| Device Name | Display, Diagnostic Radiology |
| Physical State | Hardware And Embedded Software |
| Technical Method | Hardware And Embedded Sofware For Displaying Radiological Images. |
| Target Area | Whole Body |
| Regulation Description | Picture Archiving And Communications System. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.2050 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PGY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5423 |
| Device | Display, Diagnostic Radiology |
| Product Code | PGY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Picture Archiving And Communications System. |
| CFR Regulation Number | 892.2050 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BARCO | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BARCO NV | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
BENQ CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CANON INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EIZO CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 16 | |
JVC KENWOOD CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 9 | |
KOSTEC CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 9 | |
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
QUBYX LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN BEACON DISPLAY TECHNOLOGY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
THE LINDEN GROUP CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WIDE USA CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
| Device Problems | |
|---|---|
Detachment Of Device Component | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Eizo Corporation | II | Jul-16-2015 |