# K033912: Cradle Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Cradle Technology Corp.
- Decided: May 11, 2004 after 146 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: 1 generation back to K031816 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031816: Dvnet MDV-Pacs, Dvnet International Technology Co., Ltd. (2003) Summary page 1.

## Indications for use
The CRADLE HIPAX PACS device 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. Typical users of this software system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.

Source page: https://510kreport.com/device/K033912
Methodology: https://510kreport.com/methodology