510(k) · Cleared
ClearedStereos Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biospace Med · LLZ System, Image Processing, Radiological
Cleared on Aug 29, 2008 as substantially equivalent to K010938 (Siemens Medical Solutions USA, Inc., 2001) and 1 other predicate after a 185-day review. Its family tree reaches back 5 generations to 1991. 14 later devices descend from it.
- Decided
- Aug 29, 2008
- Review
- 185 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K904519 (1991). 12 ancestors in all. 14 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 4 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 3 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 2 generations backK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- 1 generation backK071972 Orthopedic Software for Impax WorkstationsAgfa Healthcare Corp. · 2007
- This deviceK080529 Stereos WorkstationBiospace Med · 2008
- Descendant · cites it directly · 13 of its ownK090050 Stereos WorkstationBiospace Med · 2010
- Descendant · cites it directly · 12 of its ownK101398 Stereos WorkstationBiospace Med · 2011 · Recalled
- Descendant · cites it directly · 11 of its ownK113344 Stereos WorkstationEos Imaging · 2012
- Descendant · cites it directly · 10 of its ownK130395 Stereos WorkstationEos Imaging, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 9 of its ownK141137 Stereos WorkstationEos Imaging · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K090050Stereos WorkstationBiospace Med · 2010 · cites it directly13descendants
- K101398Stereos WorkstationBiospace Med · 2011 · cites it directly12descendants
- K113344Stereos WorkstationEos Imaging · 2012 · cites it directly11descendants
- K130395Stereos WorkstationEos Imaging, Inc. · 2013 · cites it directly10descendants
- K141137Stereos WorkstationEos Imaging · 2014 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −4 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −3 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −2 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| −1 | K071972 | Orthopedic Software for Impax Workstations | Agfa Healthcare Corp. | 2007 | — |
| 0 (this device) | K080529 | Stereos Workstation | Biospace Med | 2008 | — |
| +1 | K090050 | Stereos Workstation | Biospace Med | 2010 | — |
| +1 | K101398 | Stereos Workstation | Biospace Med | 2011 | 1 |
| +1 | K113344 | Stereos Workstation | Eos Imaging | 2012 | — |
| +1 | K130395 | Stereos Workstation | Eos Imaging, Inc. | 2013 | 1 |
| +2 | K141137 | Stereos Workstation | Eos Imaging | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K010938 | Syngo Multimodality WorkstationSummary page 1…892.2050; radiological image processing system Product Code: LLZ Predicate Devices: - Syngo Multimodality Workstation from Siemens Medical Systems, Inc. (K010938) - Agfa Orthopedic Software for Impax Workstations (K071972) Device Description: The SterEOS Workstation is a general pict… | 2001 |
| * | K071972 | Orthopedic Software for Impax WorkstationsSummary page 1…LLZ Predicate Devices: - Syngo Multimodality Workstation from Siemens Medical Systems, Inc. (K010938) - Agfa Orthopedic Software for Impax Workstations (K071972) Device Description: The SterEOS Workstation is a general picture archiving and communications storage system for acceptance, t… | 2007 |
What descends from it? (14)
See all 144 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)
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 17 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K090050 (Biospace Med, 2010) has gone furthest, with 13 descendants of its own.
- 12 other devices also cite its predicate K010938.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopedics in both pediatric and adult populations as a general PACS device for acceptance, transfer, display, storage, and digital processing of 2D x-ray images of the musculoskeletal system including interactive 2D measurement tools. When using 2D X-ray images obtained with the Biospace EOS System (K071546), the sterEOS Workstation provides interactive 3D…
Read the full statement (170 words)
The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopedics in both pediatric and adult populations as a general PACS device for acceptance, transfer, display, storage, and digital processing of 2D x-ray images of the musculoskeletal system including interactive 2D measurement tools.
When using 2D X-ray images obtained with the Biospace EOS System (K071546), the sterEOS Workstation provides interactive 3D measurement tools to aid in the analysis of scoliosis and related disorders and deformities of the spine in adult patients as well as pediatric patients 16 years and older. The 3D measurement tools include interactive analysis based on a model of bone structures derived from an a priori image data set from 175 patients (91 normal patients, 47 patients with moderate idiopathic scoliosis and 37 patients with severe idiopathic scoliosis), and dry isolated vertebrae data. The model of bone structures is not intended for use in patients with a Cobb's angle > 50 degrees and is not intended for use to assess individual vertebral abnormalities
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080529 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080529: Stereos Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080529
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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