SMART PCFD
by Disior, Ltd.
510(k) K250023
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250023 | Date29 Sep 2025 | StatusActive |
Official records
- FDA 510(k) database K250023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QIH
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
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.
Devices cleared under K250023
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| SMART PCFD 1 | 1 | 06429810209054 | — | On the market |
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