# K152034: FS-Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Ec-Web Co., Ltd.
- Decided: Feb 23, 2016 after 216 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: 3 generations back to K002936 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083182: Datacom DC Pacs, Datacom Technology Corp. (2009) Summary page 4.

## Indications for use
The EC-WEB FS-PACS is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using. DICOM or similar standards. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display. Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.

Source page: https://510kreport.com/device/K152034
Methodology: https://510kreport.com/methodology