For investors and partners

Prototype, not a medical device

KomPACS is a proof of concept (POC). It is not certified.

Value

• Fewer repeated CT and MR exams.
• Less staff time to collect priors.
• Priors that a NIS or PACS search does not find.

Numbers from the demo cases: Impact.

Model

• After the hackathon, a licensed Czech IT integrator owns, distributes and supports the product.
• The hospital pays the integrator.
• One container stack per hospital: on-premises, or a managed EU-cloud tenant that the integrator operates.
• The hospital changes nothing. KomPACS connects through standards the hospital already has: HL7 v2 orders, FHIR R4, a PACS availability feed.

Regulatory line

• Intended purpose: find and fetch prior imaging. KomPACS makes no diagnosis.
• A person confirms every relevance verdict.
• A human in the loop alone does not take software out of the EU Medical Device Regulation (MDR, see MDCG 2019-11). If MDR applies (Rule 11, likely class IIa), the integrator certifies the product.

Next steps

1. Pilot at one hospital with real orders.
2. Second hospital.
3. Certification, if MDR applies.

Details: Deploy for a hospital, Deployment shape.