# K031778: Practicebuilder 1-2-3

- Pathway: 510(k) (Traditional)
- Applicant: Erad Imagemedical Corp.
- Decided: Aug 7, 2003 after 58 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 K954678 (1996). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013630: Isite Radiology, Stentor, Inc. (2001)
- K022292: Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology Clinical Review Satation,Impax Ortho, Agfa Corp. (2002) Summary page 3.
- K012097: Vortex, Ultravisual Medical Systems (2001)
- (no number) Stentor iVault: named in the summary without a submission number

## Indications for use
PracficeBuilder 7-2-3is a PACS and teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. PracficeBuilder 7-2-3is for use in hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.

Source page: https://510kreport.com/device/K031778
Methodology: https://510kreport.com/methodology