510(k) · Cleared
ClearedImage Management V15
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Technologies · LLZ System, Image Processing, Radiological
Cleared on Apr 24, 2024 as substantially equivalent to K110919 (Carestream Health, Inc., 2011) after a 30-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Apr 24, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954678 (1996). 9 ancestors in all, the oldest K941223 (1994). No later device cites it as a predicate yet.
- Root · 6 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 4 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 3 generations backK020546 Fusion 7DMirada Solutions, Ltd. · 2002
- 2 generations backK083673 Carestream Pacs, Model Carestream Pacs ViiCarestream Health, Inc. · 2008
- 1 generation backK110919 Carestream PacsCarestream Health, Inc. · 2011 · Recalled
- This deviceK240822 Image Management V15Philips Medical Systems Technologies · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −5 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −4 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −3 | K020546 | Fusion 7D | Mirada Solutions, Ltd. | 2002 | — |
| −2 | K083673 | Carestream Pacs, Model Carestream Pacs Vii | Carestream Health, Inc. | 2008 | — |
| −1 | K110919 | Carestream Pacs | Carestream Health, Inc. | 2011 | 50 |
| 0 (this device) | K240822 | Image Management V15 | Philips Medical Systems Technologies | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 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? (1)
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 |
|---|---|---|---|
| * | K110919 | Carestream PacsSummary page 5…stem, Image Processing, Radiological Product Code LLZ Classification 21 CFR 892.2050 Predicate Device CARESTREAM PACS (K110919) Reference Devices Carestream Vue PACS (K122523) Carestream Vue PACS (K170580)… | 2011 |
| † | K122523 | Carestream Vue Pacs | 2012 |
| † | K170580 | Carestream Vue PACS | 2017 |
| † | K151774 | CARESTREAM Vue Motion | 2015 |
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 28 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K110919.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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?
Image Management is intended to provide complete and scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve, process and display medical images and data from hospital medical imaging and information systems. The device contains clinical applications that assist the processing, analyzing and comparing of medical images. It is a single device that integrates the review, dictation…
Read the full statement (171 words)
Image Management is intended to provide complete and scalable local and wide area PACS
solutions for hospital and related institutions/sites, which will archive, distribute, retrieve, process
and display medical images and data from hospital medical imaging and information systems.
The device contains clinical applications that assist the processing, analyzing and comparing of
medical images. It is a single device that integrates the review, dictation and reporting tools to create
a productive work environment for the radiologists and physicians.
The Image Management viewers are used for patient exam management by clinicians in order to
access and display patient data, medical reports, medical data and medical images from different
modalities including but not limited to CR, DR, CT, MR, NM, ECG, US, MG*, DBT*, OP and OPT.
The device provides wireless and portable access to medical images for remote reading or referral
purposes from web browsers using current standard HTML.
*For primary interpretation and review of mammography images, only use display hardware that is
specifically designed for and cleared by FDA for mammography.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240822 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240822: Image Management V15.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240822
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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