# K982769: Mitra Imaging Inc. Exhibit

- Pathway: 510(k) (Traditional)
- Applicant: Mitra Imaging, Inc.
- Decided: Nov 3, 1998 after 88 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K954678 (1996). 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)
- K971347: Medisurf, International Regulatory Consultants (1997) Summary page 1.

## Most influential descendants
- K992698: Stentor, Pageview (1999), 0 descendants of its own

## Recalls of this device
- Feb 13, 2002 · Not classified · Z-1128-03: Potential for incorrect body part information

## Indications for use
Exhibit is a software package, which may be marketed as a software only solution, as well as in conjunction with standard PC hardware. Exhibit is a PC-based, DICOM-compliant PACS device that is able to receive and display DICOM images. Images sent to Exhibit are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by Exhibit to create JPEG and wavelet images follow known and accepted protocols. Images sent to Exhibit can be viewed using a Java applet that runs within a web browser such as Netscape or Internet Explorer. The Exhibit applet can be used for the purposes of viewing images over a hospital intranet, or over the internet from a remote location. Images stored on Exhibit are transient, as Exhibit is not intended to be an archiving device. Exhibit uses standard “off-the-shelf’ PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to Exhibit.

Source page: https://510kreport.com/device/K982769
Methodology: https://510kreport.com/methodology