# K160852: Zia

- Pathway: 510(k) (Traditional)
- Applicant: Zetta Medical Technologies, LLC
- Decided: Dec 15, 2016 after 262 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: 3 generations back to K922470 (1992). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024028: Sharp View Image Enhancement System, Context Vision AB (2003) Summary page 4.

## Most influential descendants
- K183460: ClariCT.AI (2019), 3 descendants of its own
- K212074: ClariCT.AI (2021), 2 descendants of its own
- K254120: SubtleHD-CT (1.x) (2026), 0 descendants of its own
- K244002: AngioWaveNet (2025), 0 descendants of its own

## Indications for use
Zia™ Image Enhancement System is an image processing software that can be used for reducing noise in CT images. Enhanced images will be uploaded back to host/PACS systems and exist in conjunction to the original images. Zia™ is not intended for mammography applications. The device processing is not effective for lesion, mass, or abnormalities of sizes less than 2mm.

Source page: https://510kreport.com/device/K160852
Methodology: https://510kreport.com/methodology