# K171356: Clarity Reveal

- Pathway: 510(k) (Traditional)
- Applicant: Ceevra, Inc.
- Decided: Aug 3, 2017 after 86 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: 8 generations back to K924630 (1993). 10 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142107: Echo True 3D Viewer, Echopixel, Inc. (2015) Summary page 4.

## Most influential descendants
- K173274: Ceevra Reveal 2.0 (2018), 17 descendants of its own
- K222676: Ceevra Reveal 3 (2023), 5 descendants of its own
- K233568: Ceevra Reveal 3+ (2023), 2 descendants of its own
- K222035: Avatar Medical Software V1 (2023), 2 descendants of its own
- K211443: Aibolit 3D+ (2022), 2 descendants of its own

## Indications for use
Clarity Reveal is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning. Clarity Reveal is designed for use by healthcare professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.

Source page: https://510kreport.com/device/K171356
Methodology: https://510kreport.com/methodology