510(k) · Cleared
ClearedStandard Imaging Pipspro QA Software System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Standard Imaging, Inc. · LHO Instrument, Quality-Assurance, Radiologic
Cleared on Nov 15, 2004 as substantially equivalent to K012289 (Elekta Oncology Systems, Ltd., 2001) and 3 other predicates after a 45-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Nov 15, 2004
- Review
- 45 days
- Class
- Class I
- Product code
- LHO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K901932 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901932 | Varian Electronic Portal Imaging System | Varian Assoc., Inc. | 1991 | — |
| −1 | K955774 | Varis Portalvision | Varian Assoc., Inc. | 1996 | — |
| 0 (this device) | K042733 | Standard Imaging Pipspro QA Software System | Standard Imaging, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LHO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012289 | Modification to: Viewgt Electronic Portal Imaging Device (Epid)Summary page 1…larne Number Elektailiew/iViews Electronic Elekta Oncology Systems, Ltd. Yes -K012289 Portal Imaging Device _____________ K98 1790… | 2001 |
| * | K981790 | Iview Electronic Portal Imaging Device (Epid) Model Number IvewSummary page 1…cology Systems, Ltd. Yes -K012289 Portal Imaging Device _____________ K98 1790 Poralvsio ElctrnicPortal Varian Medical Systems. Ic… | 1998 |
| * | K003636 | PortalvisionSummary page 1…K98 1790 Poralvsio ElctrnicPortal Varian Medical Systems. Ic Yes K003636 Imaging Device ________K955774 R~T113 Rdiation Film… | 2001 |
| * | K955774 | Varis PortalvisionSummary page 1…ElctrnicPortal Varian Medical Systems. Ic Yes K003636 Imaging Device ________K955774 R~T113 Rdiation Film Radiological Imaging Yes L K952… | 1996 |
| * | — | R-T 113 Radiation Film Dosimetry Software Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All LHO devicesLHO Instrument, Quality-Assurance, Radiologic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LHO
FDA has decided no LHO device since 2007.
Median 510(k) review, days · LHO
Too few LHO 510(k)s in any year since 2007 to give a median.
Recalls per year · LHO
No recall names LHO since 2007.
Adverse event reports per year · LHO
1in 2023
MAUDE reports naming product code LHO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (237 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042733 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042733: Standard Imaging Pipspro QA Software System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042733
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026