510(k) · Cleared
ClearedAX Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 9, 1999 as substantially equivalent to K945293 (Siemens Medical Solutions USA, Inc., 1995) and 1 other predicate after an 83-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Sep 9, 1999
- Review
- 83 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K934496 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934496 | X-Ray Angiographic System | Camtronics, Ltd. | 1993 | — |
| −1 | K955519 | Analytical Review Station | Camtronics, Ltd. | 1996 | 1 |
| 0 (this device) | K992073 | AX Workstation | Siemens Medical Solutions USA, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K945293 | Top Acom StationSummary page 1…ective use of the device. Substantial Equivalence: The AX Workstation is substantially equivalent to currently marketed Siemens Medical Systems, Inc. TOP ACOM Station (K945293) with accessory ACOM.PC+ and Camtronics Analytical Review Station (K955519). Contact: Robert W. Callahan Manager of Regulatory… | 1995 |
| * | K955519 | Analytical Review StationSummary page 1…substantially equivalent to currently marketed Siemens Medical Systems, Inc. TOP ACOM Station (K945293) with accessory ACOM.PC+ and Camtronics Analytical Review Station (K955519). Contact: Robert W. Callahan Manager of Regulatory Affairs Siemens Medical Systems, Inc. 2501 North Barrington Road Hoffman E… | 1996 |
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 6 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
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?
AX Workstation will be used to independently review and process angiographic images outside of the exam room. These images are intended to assist the physician in diagnosis and treatment planning of vessel malformations and other diseases or injuries for which digital x-ray .imaging is a suitable means for visualization. Image processing functions similar to currently commercially available Siemens digital angiography systems including filtering, gray…
Read the full statement (123 words)
AX Workstation will be used to independently review and process angiographic images outside of the exam room. These images are intended to assist the physician in diagnosis and treatment planning of vessel malformations and other diseases or injuries for which digital x-ray .imaging is a suitable means for visualization. Image processing functions similar to currently commercially available Siemens digital angiography systems including filtering, gray scale windowing, zoom/roam, and subtraction will be provided to support diagnosis and treatment planning as well as quantification, report and archival functions. A multimodality viewer allows viewing of images previously acquired on computer tomographs and magnetic resonance scanners, providing viewing of different imaging modalities for the same patient on the same workstation to further support diagnosis and treatment planning.
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/K992073 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992073: AX Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992073
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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