Device Type ID | 5305 |
Device Name | Test-pattern, Radiographic |
Regulation Description | Radiologic Quality Assurance Instrument. |
Regulation Medical Specialty | Radiology |
Review Panel | Radiology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 892.1940 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | IXF |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5305 |
Device | Test-pattern, Radiographic |
Product Code | IXF |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Radiologic Quality Assurance Instrument. |
CFR Regulation Number | 892.1940 [🔎] |