# K112480: View 1 Imaging

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy America, Inc.
- Decided: Dec 13, 2011 after 106 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: 6 generations back to K945188 (1995). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063392: Imco-Stat, Imco Technologies (2006) Summary page 1.

## Indications for use
VIEWi Imaging consists of software that receives digital images and data from existing imaging equipments using DICOM 3.0 communication protocols. Images and data are stored on the server in deflate compressed image and proprietary header formats. The algorithms used to create compressed images follow known and accepted protocols, such as JPEG. VIEWi Imaging is designed to serve as an accessory to a Picture Archiving and Communication System (PACS). It is used with general purpose computing hardware for the display of medical image data and patient information. It is designed to provide storage, routing and display of DICOM image data through an executable application as well as in a web based format. VIEWi Imaging is intended for use as review tool by trained professionals, such as physicians, and must not be reviewed for primary image interpretations.

Source page: https://510kreport.com/device/K112480
Methodology: https://510kreport.com/methodology