510(k) · Cleared
ClearedAmicas Light Beam Workstation, Model 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amicas, Inc. · LLZ System, Image Processing, Radiological
Cleared on Nov 22, 2002 as substantially equivalent to K992654 (Voxar Limited, 1999) after a 77-day review. Its family tree reaches back 3 generations to 1996. 11 later devices descend from it.
- Decided
- Nov 22, 2002
- Review
- 77 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954678 (1996). 11 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 2 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 1 generation backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- This deviceK022970 Amicas Light Beam Workstation, Model 1.0Amicas, Inc. · 2002
- Descendant · cites it directly · 7 of its ownK062477 Amicas Vision Series Pacs, Model 4.3Amicas, Inc. · 2006
- Descendant · 2 generations on · 4 of its ownK073526 Amicas Vision Series Pacs, Model 5.5Amicas, Inc. · 2008
- Descendant · 3 generations on · 3 of its ownK082144 Amicas Pacs, Version 6.0Amicas, Inc. · 2008 · Recalled
- Descendant · cites it directly · 2 of its ownK051037 Imageqube PacsIntuitive Imaging Informatics, LLC · 2005
- Descendant · 4 generations on · 1 of its ownK173475 Merge PACSMerge Healthcare Incorporated · 2017 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K062477Amicas Vision Series Pacs, Model 4.3Amicas, Inc. · 2006 · cites it directly7descendants
- K073526Amicas Vision Series Pacs, Model 5.5Amicas, Inc. · 2008 · 2 generations on4descendants
- K082144Amicas Pacs, Version 6.0Amicas, Inc. · 2008 · 3 generations on3descendants
- K051037Imageqube PacsIntuitive Imaging Informatics, LLC · 2005 · cites it directly2descendants
- K173475Merge PACSMerge Healthcare Incorporated · 2017 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −2 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −1 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| 0 (this device) | K022970 | Amicas Light Beam Workstation, Model 1.0 | Amicas, Inc. | 2002 | — |
| +1 | K062477 | Amicas Vision Series Pacs, Model 4.3 | Amicas, Inc. | 2006 | — |
| +2 | K073526 | Amicas Vision Series Pacs, Model 5.5 | Amicas, Inc. | 2008 | — |
| +3 | K082144 | Amicas Pacs, Version 6.0 | Amicas, Inc. | 2008 | 13 |
| +1 | K051037 | Imageqube Pacs | Intuitive Imaging Informatics, LLC | 2005 | — |
| +4 | K173475 | Merge PACS | Merge Healthcare Incorporated | 2017 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K992654 | Plug 'N View 3D, Version 1.0Summary page 1…nington Bond 2 Anderson P1. Edinburgh, UK EH6 5NP Predicate Device 5 10(k) number: K992654 Date received: 08/09/1999 Decision date: 11/05/1999 Decision:… | 1999 |
What descends from it? (11)
See all 113 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 6 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K062477 (Amicas, Inc., 2006) has gone furthest, with 7 descendants of its own.
- 15 other devices also cite its predicate K992654.
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 AMICAS Diagnostic Workstation (ADW) is software intended for
viewing and diagnostic interpretation of images acquired from CT, MR,
CR, DR, US and other DICOM-compliant medical imaging systems when
installed on suitable commercial-standard hardware. The ADW receives
imaging studies over a network from AMICAS servers or directly from CD with images utilizing both lossless (reversible) and lossy (irreversible)
compression. It is the user's responsibility to ensure that monitor quality,
ambient light conditions and image compression ratios are consistent with
the clinical application.
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/K022970 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022970: Amicas Light Beam Workstation, Model 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022970
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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