# K140139: Clearviewhd

- Pathway: 510(k) (Traditional)
- Applicant: Clearview Diagnostics, Inc.
- Decided: May 28, 2014 after 126 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)
- K993802: Sharpview Image Enhancement System, Context Vision AB (2000) Summary page 1.
- K024028: Sharp View Image Enhancement System, Context Vision AB (2003) Summary page 1.
- K063391: Sapheneia Clarity, Sapheneia Commercial Products AB (2007) Summary page 1.

## Indications for use
The ClearView Image Enhancement System is intended for use by a qualified technician or diagnostician to reduce speckle noise, enhance contrast, and transfer ultrasound images. The software provides a DICOM-compliant ClearViewHD-enhanced image along with the original ultrasound image to assist in image interpretation by the trained physician.

Source page: https://510kreport.com/device/K140139
Methodology: https://510kreport.com/methodology