Downloadable Software as a Medical Device (SaMD) for wireless remote control of and synchronization of X-Ray machines 009-5845
无线远程控制和同步X射线机的可下载软件即医疗器械（SaMD）
Chinese
无线远程控制和同步X射线机的可下载软件即医疗器械（SaMD）
English
Downloadable Software as a Medical Device (SaMD) for wireless remote control of and synchronization of X-Ray machines
Spanish
Software descargable como dispositivo médico (SaMD) para el control remoto inalámbrico y la sincronización de máquinas de rayos X
- Term ID
- 009-5845
- Class
- 09
- Type
- Goods
- Status
- Active · added, not since modified (A)
- Effective date
- 2020-08-27
- Version
- 11-2020
Official English notes
Software as a Medical Device (SaMD) is a downloadable and/or recorded software good used for the diagnosis or treatment of a disease or health condition. SaMD runs on a computer or mobile electronic device, such as a smartphone, when performing the aforementioned functions and is not a component or integral part of medical instruments. Identifications of SaMD must indicate the particular function or purpose of the software in a manner that is sufficient to permit determinations with respect to likelihood of confusion. See TMEP §1402.03(d). SaMD is classified in Class 9 because "recorded and downloadable . . . computer software" is in the Nice Class 9 Heading.