InstaPraxis

Intended use & regulatory status

What each AI function is for, what it is not for, and where it stands with the regulator. Taken directly from the product's own device labelling.

Read this first

Every AI function on InstaPraxis is decision-support. It produces a screening indication for you to discuss with a registered medical practitioner. None of them diagnoses a disease, and none of them replaces a physical examination, a laboratory test or an imaging report issued by a qualified professional.

Current status: research use. These AI functions are published for research and screening-support use. They are not registered or licensed as medical devices with the Central Drugs Standard Control Organisation (CDSCO), and they carry no CE mark or FDA clearance. Our own classification target is CDSCO Class B software as a medical device under the Medical Devices Rules, 2017; the technical file for that submission is in preparation. Until a licence is granted, please treat every output as an indication to check, not a finding.

Each measurement is also labelled with how it was arrived at — measured (read directly from the image or signal), estimated (inferred from image texture or an acoustic model) or indicative (a rough screen a phone camera cannot do properly). Look at that label before you act on a number.

Common limitations

Function-by-function labelling

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Reporting a problem

If you believe a result was wrong in a way that mattered, please tell us — it goes into our post-market surveillance record and is investigated. See the grievance page, or write to info@instadatahelp.com with "Safety" in the subject.

© InstaDataHelp AI Services Private Limited. Manufacturer of the software described on this page.