510(k) · Cleared
ClearedAmicas Vision Series Pacs, Model 4.3
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 Oct 27, 2006 as substantially equivalent to K022970 (Amicas, Inc., 2002) after a 64-day review. Its family tree reaches back 4 generations to 1996. 7 later devices descend from it.
- Decided
- Oct 27, 2006
- Review
- 64 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954678 (1996). 7 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 3 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 2 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 1 generation backK022970 Amicas Light Beam Workstation, Model 1.0Amicas, Inc. · 2002
- This deviceK062477 Amicas Vision Series Pacs, Model 4.3Amicas, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK073526 Amicas Vision Series Pacs, Model 5.5Amicas, Inc. · 2008
- Descendant · 2 generations on · 3 of its ownK082144 Amicas Pacs, Version 6.0Amicas, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 1 of its ownK173475 Merge PACSMerge Healthcare Incorporated · 2017 · Recalled
- Descendant · 4 generations on · 0 of its ownK192455 Merge PACSMerge Healthcare Incorporated · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK124048 ImagequbeIntuitive Imaging Informatics, LLC · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K073526Amicas Vision Series Pacs, Model 5.5Amicas, Inc. · 2008 · cites it directly4descendants
- K082144Amicas Pacs, Version 6.0Amicas, Inc. · 2008 · 2 generations on3descendants
- K173475Merge PACSMerge Healthcare Incorporated · 2017 · 3 generations on1descendant
- K192455Merge PACSMerge Healthcare Incorporated · 2019 · 4 generations on0descendants
- K124048ImagequbeIntuitive Imaging Informatics, LLC · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −3 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −2 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −1 | K022970 | Amicas Light Beam Workstation, Model 1.0 | Amicas, Inc. | 2002 | — |
| 0 (this device) | K062477 | Amicas Vision Series Pacs, Model 4.3 | Amicas, Inc. | 2006 | — |
| +1 | K073526 | Amicas Vision Series Pacs, Model 5.5 | Amicas, Inc. | 2008 | — |
| +2 | K082144 | Amicas Pacs, Version 6.0 | Amicas, Inc. | 2008 | 13 |
| +3 | K173475 | Merge PACS | Merge Healthcare Incorporated | 2017 | 2 |
| +4 | K192455 | Merge PACS | Merge Healthcare Incorporated | 2019 | 4 |
| +3 | K124048 | Imageqube | Intuitive Imaging Informatics, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K022970 | Amicas Light Beam Workstation, Model 1.0Summary page 1…AMICAS Inc. 20 Guest Street Boston, MA 021235 Predicate Device 510(k) number: K022970 Date received: 09/06/2002 Decision date: 11/22/2002 Decision:… | 2002 |
What descends from it? (7)
3 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 10 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K073526 (Amicas, Inc., 2008) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K022970.
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?
Vision Series PACS 4.3 is designed and marketed for soft copy reading, communication, printing and storage of studies produced by digital modalities, to include Digital Mammography. Vision Series PACS receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems. Vision Series PACS imports images and render said images, upon request, within the…
Read the full statement (227 words)
Vision Series PACS 4.3 is designed and marketed for soft copy reading, communication, printing and storage of studies produced by digital modalities, to include Digital Mammography.
Vision Series PACS receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems.
Vision Series PACS imports images and render said images, upon request, within the AMICAS LightBeam Diagnostic Workstation utilizing both lossless (reversible) and lossy (irreversible) compression.
To support the diagnostic interpretation of Mammography studies, Vision Series PACS will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical infornation clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images should not be used for the purpose of primary diagnosis. Manmmographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Vision Series PACS formats and delivers images over a network to a FDA-cleared DICOM printer as requested and defined by the user.
Vision Series PACS must be installed on suitable, commercial-standard hardware.
It is the user's responsibility to ensure monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062477 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062477: Amicas Vision Series Pacs, Model 4.3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062477
Report an extraction error
Are you the manufacturer?
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