# K101654: Improvis Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: American Dental Partners, Inc.
- Decided: Nov 10, 2010 after 152 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 K930527 (1993). 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)
- K082623: Visix Imaging, Televere Systems (2009) Summary page 2.
- K061035: Tigerview Professional, Televere Systems (2006) Summary page 2.

## Indications for use
Improvis Imaging is a Windows-based software package that allows dental clinicians to acquire images from standard dental imaging devices and commercially available scanners, digital cameras and intra-oral cameras. It is designed to be used as an imaging database for storage and organization of patient digital images and radiographs. Features include resizing, rotating, embossing and sharpening of images. Improvis Imaging is written using three programming languages (C++, C#, TSQL) and is designed to work with standard personal computers capable of running Windows 2000 or higher. Intended users of this system are trained professionals, including but not limited to dentists, hygienists and clinical assistants.

Source page: https://510kreport.com/device/K101654
Methodology: https://510kreport.com/methodology