510(k) · Cleared
Recalled · 2011Isite Pacs, V 4. X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stentor Inc., A Philips Medical Systems Co. · LLZ System, Image Processing, Radiological
Cleared on Nov 9, 2006 as substantially equivalent to K043415 (Ge Medical Systems Information Technologies, 2005) and 2 other predicates after a 10-day review. Its family tree reaches back 5 generations to 1991. 8 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 9, 2006
- Review
- 10 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 5 generations to K913770 (1991). 12 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 4 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 3 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 2 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 1 generation backK043415 Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · Recalled
- This deviceK063267 Isite Pacs, V 4. XStentor Inc., A Philips Medical Systems Co. · 2006
- Descendant · cites it directly · 5 of its ownK111804 Intellispace Pacs 4.XPhilips Healthcare Informatics, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 3 of its ownK160315 I4 (Integrated Intelligent Imaging Informatics) systemPhilips Medical Systems Nederland B.V. · 2016
- Descendant · 3 generations on · 2 of its ownK173588 Illumeo SystemPhilips Medical Systems Technologies, Ltd. · 2018
- Descendant · 4 generations on · 1 of its ownK250181 AV ViewerPhilips Medical Systems Nederland B.V. · 2025
- Descendant · 5 generations on · 0 of its ownK261465 Indira Cloud ViewerIndigo Technologies · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K111804Intellispace Pacs 4.XPhilips Healthcare Informatics, Inc. · 2011 · cites it directly5descendants
- K160315I4 (Integrated Intelligent Imaging Informatics) systemPhilips Medical Systems Nederland B.V. · 2016 · 2 generations on3descendants
- K173588Illumeo SystemPhilips Medical Systems Technologies, Ltd. · 2018 · 3 generations on2descendants
- K250181AV ViewerPhilips Medical Systems Nederland B.V. · 2025 · 4 generations on1descendant
- K261465Indira Cloud ViewerIndigo Technologies · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −4 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −3 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −2 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −1 | K043415 | Centricity Pacs System | Ge Medical Systems Information Technologies | 2005 | 23 |
| 0 (this device) | K063267 | Isite Pacs, V 4. X | Stentor Inc., A Philips Medical Systems Co. | 2006 | — |
| +1 | K111804 | Intellispace Pacs 4.X | Philips Healthcare Informatics, Inc. | 2011 | 2 |
| +2 | K160315 | I4 (Integrated Intelligent Imaging Informatics) system | Philips Medical Systems Nederland B.V. | 2016 | — |
| +3 | K173588 | Illumeo System | Philips Medical Systems Technologies, Ltd. | 2018 | — |
| +4 | K250181 | AV Viewer | Philips Medical Systems Nederland B.V. | 2025 | — |
| +5 | K261465 | Indira Cloud Viewer | Indigo Technologies | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K043415 | Centricity Pacs SystemSummary page 1…Code: LLZ 1.5 Substantial Equivalence Manufacturer: General Electric Medical Systems Model: GE Centricity PACS 510(k) Number: K043415 Manufacturer: Eastman Kodak Company Model: Kodak PACS 510(k) Number: K060055 Manufacturer: Sten… | 2005 |
| * | K060055 | Kodak PacsSummary page 1…al Systems Model: GE Centricity PACS 510(k) Number: K043415 Manufacturer: Eastman Kodak Company Model: Kodak PACS 510(k) Number: K060055 Manufacturer: Stentor, Inc. Model: iSite PACS 3.3 510(k) Number: K042292… | 2006 |
| * | K042292 | Isite PacsSummary page 1…Eastman Kodak Company Model: Kodak PACS 510(k) Number: K060055 Manufacturer: Stentor, Inc. Model: iSite PACS 3.3 510(k) Number: K042292 /t Philips Company Confidential Page 1 of 2… | 2004 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 23, 2011 | Not classified | Z-1881-2011 | Software design | A software anomaly that occurs when clinicians use Volume Vision to view images in 3D and uses the measurement tool to measure regions of interest. This could lead to an incorrect interpretation of the measurements which could cause an… |
| Dec 29, 2008 | Not classified | Z-0948-2009 | Software design | Product may display clinical reports with the study date and time in GMT format, which may not be obvious to the end user, who may expect to see the local time in the report. |
| Aug 29, 2008 | Not classified | Z-0118-2009 | Software design | Two defects have been identified: 1) potential to display a patient on the canvas page that is different from the patient whose images are displayed on diagnostic monitors when using Conference Presentation States and when opening two or… |
| Jan 29, 2008 | Not classified | Z-1444-2008 | Software design | When using the Freehand Region of Interest (ROI) tool, errors may occur in area calculation yielding incorrect results. The firm discovered that a descrepancy exists in the measurement provided by the tool. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K111804 (Philips Healthcare Informatics, Inc., 2011) has gone furthest, with 5 descendants of its own.
- 10 other devices also cite its predicate K043415.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
iSite PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. Lossy compressed…
Read the full statement (106 words)
iSite PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063267 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063267: Isite Pacs, V 4. X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063267
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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