# K983111: Xray Vision

- Pathway: 510(k) (Traditional)
- Applicant: Apteryx, Inc.
- Decided: Nov 16, 1998 after 73 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: 2 generations back to K930527 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955237: Tigerscan/Tigerview, Tau Corp. (1996) Summary page 1.

## Most influential descendants
- K072665: Suniray 5.2 (2007), 0 descendants of its own

## Indications for use
Uses for XrayVision in the dental industry are as follows: Permits sending of data by email, client/server, ftp, phone and floppy disk Organize and archive x-rays and patient related files Facilitate sharing and transmission of information between doctors, other applications and other computers Ability to place markers and annotations on x-rays for diagnostic purposes Allows user to take calibrated measurements Provide image-processing tools such as sharpening, colorizing, resizing, etc. (none of which physically alter images). Electronic transmission of images to insurance companies or specialist When using XrayVision for diagnostic purposes the general public will be the doctor/dentist population. This software is primarily used to store a patient’s imaging data (i.e. x-rays) in a form compatible with today’s networked online practice management software. This software may also be used to transmit radiographs to specialists who will be treating the patient or the insurance company for approval of procedure and etc.

Source page: https://510kreport.com/device/K983111
Methodology: https://510kreport.com/methodology