# K063294: Topacs

- Pathway: 510(k) (Traditional)
- Applicant: Radiological Specialists, Inc.
- Decided: Jan 24, 2007 after 84 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 K955092 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030781: Kodak Directview Pacs/Image Management System, Kodak Directview Workflow Manager,Kodak Directview CX/DX, Kodak Directvib, Eastman Kodak Company (2003) Summary page 2.
- K023460: Pacsplus, Medical Standard Co., Ltd. (2003) Summary page 2.
- K031562: Ramsoft Pacs, Model 3.0, Ramsoft, Inc. (2003) Summary page 2.

## Indications for use
The Thoth ToPACS is an image management system whose intended use is to provide (scaleable ) DICOM compatible PACS solutions for hospital and related institutions/sites, which will archive/ distribute/ retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR and other devices) and information systems. Lossy Compressed Mammographic Images and Digitized Film Screen Images must not be reviewed for primary Image interpretations. Mammographic Images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other specifications reviewed and accepted by FDA

Source page: https://510kreport.com/device/K063294
Methodology: https://510kreport.com/methodology