# K212550: Hura CTP v1.0

- Pathway: 510(k) (Traditional)
- Applicant: Hura Imaging, Inc.
- Decided: Nov 8, 2021 after 87 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922470 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063391: Sapheneia Clarity, Sapheneia Commercial Products AB (2007) Summary page 7.

## Indications for use
Hura CTP™ v1.0 is intended as an image processing software to reduce noise of head CT Perfusion (CTP) DICOM images through multiple algorithm steps. The software reduces image noise and enhances image contrast (e.g. contrast-to-noise ratio (CNR) and signal-to-noise ratio (SNR)) of the CTP DICOM images. Hura CTP™ v1.0 is non-iterative; hence the low computational overhead enables fast processing and allows no interruption to clinical workflow. Hura CTP™ v1.0 outputs head CTP DICOM images with enhanced image quality to a designated directory defined by the user. The processed DICOM images can be imported to a third-party post-processing software for quantification of hemodynamic parameters. The use of this algorithm may enhance the image contrast of head CTP DICOM images depending on the clinical task, patient size, and clinical practice. A consultation with a radiologist and a physicist should be made to determine the appropriate imaging protocol to obtain diagnostic image quality for the clinical task. Hura CTP™ v1.0 is intended for use only by trained and qualified clinical personnel (e.g. radiologists). Hura CTP™ v1.0 is also intended to be used by trained and qualified personnel for installation and maintenance of the software.

Source page: https://510kreport.com/device/K212550
Methodology: https://510kreport.com/methodology