# K042733: Standard Imaging Pipspro QA Software System

- Pathway: 510(k) (Traditional)
- Applicant: Standard Imaging, Inc.
- Decided: Nov 15, 2004 after 45 days
- Product code: LHO (Instrument, Quality-Assurance, Radiologic)
- Device class: 1
- Regulation: 21 CFR 892.1940
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K901932 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012289: Modification to: Viewgt Electronic Portal Imaging Device (Epid), Elekta Oncology Systems, Ltd. (2001) Summary page 1.
- K981790: Iview Electronic Portal Imaging Device (Epid) Model Number Ivew, Elekta Oncology Systems, Ltd. (1998) Summary page 1.
- K003636: Portalvision, Varian Medical Systems, Inc. (2001) Summary page 1.
- K955774: Varis Portalvision, Varian Assoc., Inc. (1996) Summary page 1.
- (no number) R-T 113 Radiation Film Dosimetry Software: named in the summary without a submission number

## Indications for use
PIPSpro QA Software System (Portal Imaging Processing System, professional version) is a stand-alone software program for use on PC computers running under Microsoft Windows 9x/Me/2000/NT/XP. The PC is not supplied with PIPSpro, and must be provided by the user. PIPSpro is supplied on a CD together with a software security key ("dongal" or hard lock) which is inserted into a parallel or USIB port on the computer to allow the software to work. PIPSpro does not use, control, or operate any hardware, it is purely a stand-alone software program. AQUA is also a stand-alone software program, consisting of a small part of the PIPSpro system. AQUA includes only those routines required for the analysis of images acquired with the QC-3 phantom, and used for quality control of electronic portal imaging devices. The PIPSpro QA Software System displays, enhances and analyses portal images, and is used in conjunction with commercially available electronic portal imaging detectors (EPIDs). PIPSpro provides numerous measurement tools, image processing routines, statistical analysis and capabilities that are not available in the standard software provided by the EPID suppliers. These include the processing of simulator and portal verification images, analyzing patient registration errors, measuring of image quality from an EPID duning installation tests, providing a platform for quality assurance programs in radiation therapy, and tools for writing and editing notes attached to images for easy communication. In this capacity, it can only import images and information.

Source page: https://510kreport.com/device/K042733
Methodology: https://510kreport.com/methodology