# K173274: Ceevra Reveal 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Ceevra, Inc.
- Decided: Jul 10, 2018 after 271 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: 9 generations back to K924630 (1993). 11 ancestors in all.
17 later devices descend from it; 6 cite 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)
- K171356: Clarity Reveal, Ceevra, Inc. (2017) Summary page 4.

## Most influential descendants
- 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
- K182643: IRIS 1.0 System (2019), 2 descendants of its own

## Indications for use
Ceevra Reveal 2.0 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, and as software for the intraoperative display of the aforementioned multi-dimensional digital images. Ceevra Reveal 2.0 is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.

Source page: https://510kreport.com/device/K173274
Methodology: https://510kreport.com/methodology