Recognized standard
RT2:2017
FDA recognition 12-307 · AAMI · Radiology
Key facts
| Recognition number | 12-307 |
|---|---|
| Designation | RT2:2017 |
| Title | Radiation therapy readiness check |
| Standards developer | Association for the Advancement of Medical Instrumentation |
| Specialty area | Radiology |
| Date of entry | Dec 4, 2017 |
| Device classes | Class 2 |
| Scope (excerpt) | AAMI RT2:2017 defines specific patient safety features that can be made available in compliant radiotherapy equipment, if and as applicable to that equipment. It provides a mechanism by which manufacturers can provide information to operators, responsible organizations, and regulators detailing how… |
At a glance
- 1–9 Product codes
- None FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: