Is your device active and intended to emit ionizing radiation and intended for diagnostic or therapeutic radiology (including interventional radiology devices and devices which control or monitor such devices, or which directly influence their performance)?

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Ionizing radiation (ionising radiation) is radiation, traveling as a particle or 

electromagnetic wave, that carries sufficient energy to detach electrons 

from atoms or molecules, thereby ionizing 

an atom or a molecule.

Is your device active and intended for diagnosis and monitoring ?

 
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Active device intended for diagnosis and monitoring means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physio­ logical conditions, states of health, illnesses or congenital deformities.

Is your active device intended to supply energy which will be absorbed by the human body?

 
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Active device means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.

Software shall also be deemed to be an active device.

Is your active device intended to illuminate the patient's body, in the visible spectrum?

 
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Active device means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.

Software shall also be deemed to be an active device.

Is your active device intended to image in vivo distribution of radiopharmaceuticals?

 

In vivo (Latin: (with)in the living) means that which takes place inside an organism. In science, in vivo refers to experimentation done in or on the living tissue of a whole, living organism as opposed to a partial or dead one. Animal testing and clinical trials are forms of in vivo research.

Is your active device intended to allow direct diagnosis or monitoring of vital physiological processes?

 
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Active device means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.

Software shall also be deemed to be an active device.

 

Is your active device specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of the central nervous system, or they are intended for diagnosis in clinical situations where the patient is in immediate danger?

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Central nervous system means the brain, meninges and spinal cord.