# K070397: Dgscope, Release 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Segami Corporation
- Decided: Apr 13, 2007 after 60 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
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K080608: Digital Lightbox (2008), 6 descendants of its own
- K093117: Digital Lightbox (2009), 5 descendants of its own
- K153653: DICOM Viewer (2016), 4 descendants of its own
- K191014: Elements Viewer (2020), 3 descendants of its own
- K232759: Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout (2024), 1 descendant of its own

## Indications for use
The DGSCOPE system is indicated for the review of diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. The DGSCOPE system displays the processed images using an integrated computer. The DGSCOPE's PC's surfaces can be disinfected using an FDA approved liquid disinfectant indicating that the use of the DGSCOPE system is appropriate in an operating room environment. The display of CT, MR, X-Ray, NM, US, and other diagnostic data is in the standard planar and pseudo-three dimensional formats in both static and dynamic review modes.This device is not used in the primary diagnosis of Mammography images.

Source page: https://510kreport.com/device/K070397
Methodology: https://510kreport.com/methodology