# K133373: Clearview

- Pathway: 510(k) (Traditional)
- Applicant: Neusoft Medical Systems Co., Ltd.
- Decided: Dec 3, 2014 after 397 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K982349 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121792: Neuviz 64 Multi-Slice CT Scanner System, Neusoft Medical Systems Co., Ltd. (2012) Summary page 6.

## Indications for use
ClearView is a CT reconstruction software. The end user can choose to apply either ClearView or the filter back-projection (FBP) to the acquired raw data. Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of ClearView can help to reduce radiation dose while maintaining Pixel noise, low contrast detectability and high contrast resolution. Phantom measurements showed that high contrast resolution and pixel noise are equivalent between full dose FBP images and reduced dose ClearView images. Additionally, ClearView can reduce body streak artifacts by using iterations between image space and raw data space. A Model Observer evaluation showed that equivalent low contrast detectability can be achieved with less dose using ClearView at highest noise reduction level for thin (0.625 mm) reconstruction slices in MITA body and ACR head phantoms for low contrast objects with different contrasts. ClearView are not intended to be used in CCT and Pilot.

Source page: https://510kreport.com/device/K133373
Methodology: https://510kreport.com/methodology