PACS for CE
- Thread starter mikezv
- Start date
dgrainger
Trusted Information Resource
The old Borderline manual has an entry on PACS that might be of use. But might be overtaken by Rule 11.
8.4. Picture Archiving and Communication Systems (PACS)
- Background
Basically, a PACS workstation is specifically designed to be networked with a wide variety of diagnostic imaging systems, e.g. x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound, as well as laboratory or hospital information systems. It does not contain
controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is typically located at a site remote from imaging systems and is configured to provide limited or extensive capabilities to further
process, manipulate and/or view patient images and information collected from diagnostic imaging systems. The manufacturer of the PACS states that the system does not influence the radiation of the diagnostic x-ray machine.
Generally speaking there are various types of PACS:
(a) PACS used for viewing, archiving and transmitting images.
(b) Where the post-processing of the image for diagnostic purposes is such as:
- image processing functions which alter the image data (e.g. filtering, multiplanar reconstruction, 3D reconstruction)
- complex quantitative functions (e.g. arterial stenosis evaluation, ventricular volume calculation, calcium scoring, automatic indication (detection) of potential lesions
(c) With image enhancing by controlling image acquisition
- Outcome
In cases where the PACS falls under the definition of a medical device, i.e. is specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the medical device definition, the following situations can be foreseen:
(i) In relation to PACS (a) intended by its manufacturer to be used for viewing, archiving and transmitting images, it is considered that applying rule 12 could be appropriate and accordingly this type of PACS are generally classified as Class I medical devices. However,
PACS that are only intended for archiving or storage of data may not fall within the definition of a medical device provided that data is not manipulated.
(ii) Those types of PACS (b) which drive a device or influence the use of a source device fall automatically in the same class in accordance with implementing rule 2.3, which classifies them as Class IIa or IIb. If this type of PACS does not drive or influence the use of the source
device, this type of PACS can be classified under rule 10 if such PACS are intended to allow direct diagnosis, classifying them as Class IIa.
(iii) PACS with image enhancing by controlling image acquisition (c) should fall into the same class as the source device. This is based upon, firstly, implementing rule 2.3”Software, which drives a device or influences the use of a device, falls automatically in the same class.” and the last paragraph of MEDDEV 2.4/1 - rev. 8, Section 3.2 stating that: "Standalone software, e.g. software which is used for image enhancement is regarded as driving or influencing the use of a device and so falls automatically into the same class. Other standalone software, which is not regarded as driving or influencing the use of a device, is classified in its own right". Applying this classification rule and the interpretation of the MEDDEV allows this type of PACS to be classified as Class IIa or IIb medical devices according to the classification of the device itself.