510(k) · Cleared
Recalled · Class II · 2017Amicas Pacs, Version 6.0
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 Sep 5, 2008 as substantially equivalent to K073526 (Amicas, Inc., 2008) after a 37-day review. Its family tree reaches back 6 generations to 1996. 3 later devices descend from it. It has been recalled 13 times.
- Decided
- Sep 5, 2008
- Review
- 37 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 13
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954678 (1996). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 4 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 3 generations backK022970 Amicas Light Beam Workstation, Model 1.0Amicas, Inc. · 2002
- 2 generations backK062477 Amicas Vision Series Pacs, Model 4.3Amicas, Inc. · 2006
- 1 generation backK073526 Amicas Vision Series Pacs, Model 5.5Amicas, Inc. · 2008
- This deviceK082144 Amicas Pacs, Version 6.0Amicas, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK173475 Merge PACSMerge Healthcare Incorporated · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK192455 Merge PACSMerge Healthcare Incorporated · 2019 · Recalled
- Descendant · cites it directly · 0 of its ownK124048 ImagequbeIntuitive Imaging Informatics, LLC · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −5 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −4 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −3 | K022970 | Amicas Light Beam Workstation, Model 1.0 | Amicas, Inc. | 2002 | — |
| −2 | K062477 | Amicas Vision Series Pacs, Model 4.3 | Amicas, Inc. | 2006 | — |
| −1 | K073526 | Amicas Vision Series Pacs, Model 5.5 | Amicas, Inc. | 2008 | — |
| 0 (this device) | K082144 | Amicas Pacs, Version 6.0 | Amicas, Inc. | 2008 | — |
| +1 | K173475 | Merge PACS | Merge Healthcare Incorporated | 2017 | 2 |
| +2 | K192455 | Merge PACS | Merge Healthcare Incorporated | 2019 | 4 |
| +1 | K124048 | Imageqube | Intuitive Imaging Informatics, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K073526 | Amicas Vision Series Pacs, Model 5.5Summary page 1…AMICAS Inc. 20 Guest Street Boston, MA 021235 Predicate Device 5 10(k) number: K073526 Date received: 12/17/2007 Decision date: 03/12/2008 Decision:… | 2008 |
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 24, 2017 | Class II | Z-2601-2017 | Software design (manufacturing process) | Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server. |
| May 8, 2017 | Class II | Z-2590-2017 | Software design (manufacturing process) | Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing. |
| May 8, 2017 | Class II | Z-2591-2017 | Software design (manufacturing process) | When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis. |
| Apr 4, 2016 | Class II | Z-1431-2017 | Software design | Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server. |
| Apr 4, 2016 | Class II | Z-1176-2017 | Software design | Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment. |
| Mar 28, 2016 | Class II | Z-0599-2017 | Software design | The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing. |
| Mar 28, 2016 | Class II | Z-0726-2017 | Component design/selection | Cut lines on the image may present horizontally rather than vertically. |
| Feb 5, 2016 | Class II | Z-2363-2016 | Software design | When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same. |
| Jan 30, 2016 | Class II | Z-2301-2016 | Software design | Studies coming over via telmed were missing patient's DOB, procedure, and referring physician. |
| Jan 30, 2016 | Class II | Z-2303-2016 | Software design | A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations. |
| Jan 30, 2016 | Class II | Z-2379-2016 | Software design | The patient name in the Halo title bar and the thumbnails do not match the name on displayed images. |
| Jan 30, 2016 | Class II | Z-2531-2016 | Software design | Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were… |
| Jan 30, 2016 | Class II | Z-2532-2016 | Software design | Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were… |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K173475 (Merge Healthcare Incorporated, 2017) has gone furthest, with 1 descendant of its own.
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?
AMICAS PACS 6.0 is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, to include Digital Mammography. AMICAS PACS 6.0 receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems. AMICAS PACS 6.0 imports images and render said images, upon request, within the viewer component…
Read the full statement (332 words)
AMICAS PACS 6.0 is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, to include Digital Mammography. AMICAS PACS 6.0 receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems.
AMICAS PACS 6.0 imports images and render said images, upon request, within the viewer component utilizing both lossless (reversible) and lossy (irreversible) compression.
To support the diagnostic interpretation of Mammography studies, AMICAS PACS 6.0 will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information 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 must not be used for the purpose of primary diagnosis. Mammographic 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.
Within AMICAS PACS 6.0, the AMICAS Real Time Worklist offers real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, and configurable, components within the Real Time Worklist.
AMICAS PACS 6.0 also offers the Patient Dashboard which provides a single view of all patient data, both imaging and non-imaging.
AMICAS Reach is an optional component within AMICAS PACS 6.0 which provides clinicians secure, proactive communication and access to clinical reports and images.
Order and Report information generated by HIS/RIS and report creation systems are received and displayed in PACS via the transmission of HL7 messaging. For this data, AMICAS PACS 6.0 is not the creator, but instead the downstream recipient which relies on the validity of data from said systems.
AMICAS PACS 6.0 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/K082144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082144: Amicas Pacs, Version 6.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082144
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