Recognized standard
61217 Edition 2.0 2011-12
FDA recognition 12-267 · IEC · Radiology
Key facts
| Recognition number | 12-267 |
|---|---|
| Designation | 61217 Edition 2.0 2011-12 |
| Title | Radiotherapy equipment - Coordinates, movements, and scales |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | This International Standard applies to equipment and data related to the process of TELERADIOTHERAPY, including PATIENT image data used in relation with RADIOTHERAPY TREATMENT PLANNING SYSTEMS, RADIOTHERAPY SIMULATORS, isocentric GAMMA BEAM THERAPY EQUIPMENT, isocentric medical ELECTRON… |
At a glance
- 10–99 Product codes
- 1–9 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: