Device Type ID | 5277 |
Device Name | Assembly, Tube Housing, X-ray, Diagnostic |
Regulation Description | Diagnostic X-ray Tube Housing Assembly. |
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 | 892.1760 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | ITY |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |