510(k) · Cleared
Recalled · 2011Isite Pacs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stentor, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 8, 2004 as substantially equivalent to K023557 (GE Medical Systems, 2002) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 1992. 15 later devices descend from it. It has been recalled 7 times.
- Decided
- Sep 8, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 2 generations to K920319 (1992). 4 ancestors in all. 15 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK920319 Sienet Image Display Workstations, Image AcquisitiSiemens Gammasonics, Inc. · 1992
- 1 generation backK023557 Centricity Pacs PlusGE Medical Systems · 2002
- This deviceK042292 Isite PacsStentor, Inc. · 2004
- Descendant · cites it directly · 8 of its ownK063267 Isite Pacs, V 4. XStentor Inc., A Philips Medical Systems Co. · 2006 · Recalled
- Descendant · 2 generations on · 5 of its ownK111804 Intellispace Pacs 4.XPhilips Healthcare Informatics, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 3 of its ownK160315 I4 (Integrated Intelligent Imaging Informatics) systemPhilips Medical Systems Nederland B.V. · 2016
- Descendant · 4 generations on · 2 of its ownK173588 Illumeo SystemPhilips Medical Systems Technologies, Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK051809 Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data…Medical Insight A/S · 2005
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K063267Isite Pacs, V 4. XStentor Inc., A Philips Medical Systems Co. · 2006 · cites it directly8descendants
- K111804Intellispace Pacs 4.XPhilips Healthcare Informatics, Inc. · 2011 · 2 generations on5descendants
- K160315I4 (Integrated Intelligent Imaging Informatics) systemPhilips Medical Systems Nederland B.V. · 2016 · 3 generations on3descendants
- K173588Illumeo SystemPhilips Medical Systems Technologies, Ltd. · 2018 · 4 generations on2descendants
- K051809Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data Management SystemMedical Insight A/S · 2005 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920319 | Sienet Image Display Workstations, Image Acquisiti | Siemens Gammasonics, Inc. | 1992 | — |
| −1 | K023557 | Centricity Pacs Plus | GE Medical Systems | 2002 | — |
| 0 (this device) | K042292 | Isite Pacs | Stentor, Inc. | 2004 | — |
| +1 | K063267 | Isite Pacs, V 4. X | Stentor Inc., A Philips Medical Systems Co. | 2006 | 4 |
| +2 | K111804 | Intellispace Pacs 4.X | Philips Healthcare Informatics, Inc. | 2011 | 2 |
| +3 | K160315 | I4 (Integrated Intelligent Imaging Informatics) system | Philips Medical Systems Nederland B.V. | 2016 | — |
| +4 | K173588 | Illumeo System | Philips Medical Systems Technologies, Ltd. | 2018 | — |
| +1 | K051809 | Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data… | Medical Insight A/S | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K023557 | Centricity Pacs PlusSummary page 1…ode: LLZ 1.5 Substantial Equivalence Manufacturer: General Electric Medical Systems Model: Centricity PACS Plus 510(k) Number: K023557 Manufacturer: Eastman Kodak Company Model: Kodak DirectView PACS 510(k) Number: K030781 1.6 Device… | 2002 |
| * | K030781 | Kodak Directview Pacs/Image Management System, Kodak Directview Workflow Manager,Kodak…Summary page 1…Model: Centricity PACS Plus 510(k) Number: K023557 Manufacturer: Eastman Kodak Company Model: Kodak DirectView PACS 510(k) Number: K030781 1.6 Device Description and Intended Use iSite is an image management system intended to be used by trained professi… | 2003 |
What descends from it? (15)
See all 154 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… |
| 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… |
| Jul 3, 2008 | Not classified | Z-2346-2008 | Software design | Scout line and localizer crosshair on MPR images will display in the incorrect position under certain circumstances. |
| Jan 29, 2008 | Not classified | Z-1443-2008 | 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. |
| Jan 4, 2008 | Not classified | Z-1141-2008 | Software design | Incorrect display of one of the patient's images. This malfunction could cause an image to be incorrectly displayed, for example flipped left to right and anterior to posterior. The original image is still presented in the correct… |
| Feb 14, 2007 | Not classified | Z-0616-2007 | Other | A defect may cause patient image orientation markers to be incorrectly labeled on Multi-Planar Reformation (MPR) images. Left and Right Anatomical orientation markers may be reversed. |
| Dec 20, 2005 | Not classified | Z-0399-06 | Other | When using a third party dictation accessory with the iSite PACS, a malfunction may occur that would result in the petient/exam selected and shown may be different on the radiologist console and diagnostic display screens |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K063267 (Stentor Inc., A Philips Medical Systems Co., 2006) has gone furthest, with 8 descendants of its own.
- 5 other devices also cite its predicate K023557.
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 used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging device or modalities. Lossy compressed mammographic images and digitized film screen…
Read the full statement (103 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 used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging device or modalities.
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/K042292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042292: Isite Pacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042292
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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