Downloadable Software as a Medical Device (SaMD) for diagnosing and treating {indicate disease or physical condition, e.g., sleep apnea, post-traumatic stress disorders, large vessel occlusion strokes, etc.} 009-5841
诊断和治疗{指明疾病或身体状况，例如睡眠呼吸暂停、创伤后应激障碍、大血管闭塞性卒中等}的可下载软件即医疗器械（SaMD）
Chinese
诊断和治疗{指明疾病或身体状况，例如睡眠呼吸暂停、创伤后应激障碍、大血管闭塞性卒中等}的可下载软件即医疗器械（SaMD）
English
Downloadable Software as a Medical Device (SaMD) for diagnosing and treating {indicate disease or physical condition, e.g., sleep apnea, post-traumatic stress disorders, large vessel occlusion strokes, etc.}
Spanish
Software descargable como dispositivo médico (SaMD) para el diagnóstico y tratamiento de {indique la enfermedad o afección física, por ejemplo, apnea del sueño, trastornos de estrés postraumático, accidentes cerebrovasculares por oclusión de grandes vasos, etc.}
- Term ID
- 009-5841
- 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.