Accessory to a PACS (Picture Archiving and Communication System) system?

E

esalsan

#1
Dear covers,

This is a theoretical situation. Lets say I am a manufacturer of a piece of software that generates invoices based on diagnostic tests performed. My software is not a medical device (only intended to generate invoices) and can obtain the information I need from many sources, one of which could be a PACS (Picture Archiving and Communication System) in a hospital.

The PACS is classified as a medical device.

My software does then include some lines of code (perhaps wrapped into a component) that allows the information I need to be obtained from the PACS.

I am getting some discussions around whether the software/component would be an accessory to the PACS so based on the definition of accessory in the directive:
- it is not intended specifically by us to be used together with the PACS
because: an operator could enter the information manually and we can also connect with many other types of financial systems.
- The PACS works as intended by its manufacturer without the need or our software, i.e., in the words of the directive: it does not 'enable the device to be used in accordance with the use of the device intended by the manufacturer of the device'.

Is this correct?

Note: I have interpreted the 'it' in bold below to mean 'the device' in the definition of accessory:
any article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device.

Thank you!
 
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E

esalsan

#4
Thank you very much for your opinions. And now the "what if(s)"...

Would the situation change if our software could only accept data from a PACS but would work with any brand (from any manufacturer) or model of PACS?

I don't think that in this situation our software would be an accessory either because: is not intended to be use with a specific device but rather with a type of devices; and also, neither of those PACS need our software to function as intended by their manufacturers.

Is this interpretation correct?

Thanks!
 
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