510(k) · Cleared
ClearedStrykerware System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · LLZ System, Image Processing, Radiological
Cleared on Mar 10, 2003 as substantially equivalent to K994228 (Etrauma.Com Corp., 2000) and 1 other predicate after an 83-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Mar 10, 2003
- Review
- 83 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K924178 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK924178 Medvision (TM) Imaging SoftwareEvergreen Technologies, Inc. · 1993
- 2 generations backK970064 Amicas Web/Intranet Image ServerAutocyt Group, Inc. · 1997
- 1 generation backK994228 Remoteimage SystemEtrauma.Com Corp. · 2000
- This deviceK024159 Strykerware SystemStryker Endoscopy · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924178 | Medvision (TM) Imaging Software | Evergreen Technologies, Inc. | 1993 | — |
| −2 | K970064 | Amicas Web/Intranet Image Server | Autocyt Group, Inc. | 1997 | — |
| −1 | K994228 | Remoteimage System | Etrauma.Com Corp. | 2000 | — |
| 0 (this device) | K024159 | Strykerware System | Stryker Endoscopy | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K994228 | Remoteimage SystemSummary page 1…m is substantially equivalent in safety and efficacy as the currently marketed RemotelmageTMS m and AMICAS Webllntranet Image Server which were cleared under 51OK#'s K994228 and K970064 respectively. The Stryker StrykerwareTM PACS System is a medical system that is designed to allow access to medical… | 2000 |
| * | K970064 | Amicas Web/Intranet Image ServerSummary page 1…tially equivalent in safety and efficacy as the currently marketed RemotelmageTMS m and AMICAS Webllntranet Image Server which were cleared under 51OK#'s K994228 and K970064 respectively. The Stryker StrykerwareTM PACS System is a medical system that is designed to allow access to medical images and r… | 1997 |
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 10 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 4 ancestors has a recall.
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?
The StrykerwareTM PACS System is a system designed to provide licensed medical professionals access to medical images. This product is intended to be used for reviewing and storing images from a variety of modalities. StrykerWareTM is the system with software installed on a computer configured with connections to image acquisition devices, image storage locations and the internet. The system facilitates the transferal of images between local and remote…
Read the full statement (100 words)
The StrykerwareTM PACS System is a system designed to provide licensed medical professionals access to medical images. This product is intended to be used for reviewing and storing images from a variety of modalities. StrykerWareTM is the system with software installed on a computer configured with connections to image acquisition devices, image storage locations and the internet. The system facilitates the transferal of images between local and remote locations (including but not limited to a licensed medical professional’s operating suite). The users of StrykerwareTM are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, and urologists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024159: Strykerware System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024159
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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