Identifiers
- 510(k) Number
- K250023 FDA 510(k)
- FDA Product Code
- QIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
SMART PCFD is an AI-enabled medical device in the Radiology specialty. It is a cloud-based service that processes DICOM data via HTTPS connection to provide three-dimensional analysis from medical images.
The device is supplied as a software service requiring an internet connection for data transfer. It received FDA 510(k) clearance (K250023) on September 29, 2025, with a traditional clearance pathway and product code QIH. The device is intended for use by specialist clinicians to obtain objective data for diagnosis, treatment planning, and assessment of treatment outcomes.
Frequently asked questions
What is the SMART PCFD device intended for?
The SMART PCFD device is intended for use by specialist clinicians to obtain objective data for diagnosis, treatment planning, and assessment of treatment outcomes through three-dimensional analysis of medical images.
How is the SMART PCFD device supplied and accessed?
The SMART PCFD device is supplied as a cloud-based software service that requires an internet connection to process DICOM data via HTTPS for three-dimensional image analysis.
What regulatory pathway was used for the SMART PCFD device?
The SMART PCFD device received FDA 510(k) clearance through a traditional clearance pathway, with the submission number K250023 and product code QIH.
Who manufactures the SMART PCFD device and where is it located?
The SMART PCFD device is manufactured by Disior, Ltd., located at Htc Helsinki, Bldg. Pinta, Tammasaarenkatu 3, Helsinki Uusimaa, Finland, with postal code 00180.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Disior® Ltd - SMART28℠ - smart.paragon28.com, K250023 FDA 510 (k) - SMART PCFD | Disior, Ltd., SMART PCFD (K250023) — FDA 510 (k) | Innolitics, Disior Ltd: SMART PCFD (FDA-cleared AI medical device), SMART PCFD - Physician AI Tools
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250023 | Class II | Active |
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Manufacturer
- Manufacturer
- Disior, Ltd.
Sources (1)
- FDA 510(k) K250023 24 fields · synced Sep 19, 2026