510(k) · Cleared
ClearedPro Vision
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Algotec Systems, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Jul 20, 1998 as substantially equivalent to K954678 (Algotec Systems, Ltd., 1996) after a 151-day review. Its family tree reaches back 1 generation to 1996. 1 of the 674 devices in its family, counting itself, has a Class I recall. 672 later devices descend from it.
- Decided
- Jul 20, 1998
- Review
- 151 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954678 (1996). 672 later devices descend from it, 2 citing it directly. 1 of the 674 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- This deviceK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- Descendant · cites it directly · 670 of its ownK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- Descendant · 2 generations on · 442 of its ownK020546 Fusion 7DMirada Solutions, Ltd. · 2002
- Descendant · 2 generations on · 252 of its ownK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- Descendant · 3 generations on · 226 of its ownK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- Descendant · 4 generations on · 217 of its ownK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
Showing 5 of 672 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025
Most influential descendants
Showing 5 of 672 · See all- K992654Plug 'N View 3D, Version 1.0Voxar Limited · 1999 · cites it directly670descendants
- K020546Fusion 7DMirada Solutions, Ltd. · 2002 · 2 generations on442descendants
- K022692Voxelplus PacsMevisys Co., Ltd. · 2002 · 2 generations on252descendants
- K051528Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005 · 3 generations on226descendants
- K061696Iqqa-Liver SoftwareEdda Technology, Inc. · 2006 · 4 generations on217descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| 0 (this device) | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| +1 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| +2 | K020546 | Fusion 7D | Mirada Solutions, Ltd. | 2002 | — |
| +2 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| +3 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| +4 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 9 | 0 |
| 2005 | 10 | 0 |
| 2006 | 16 | 0 |
| 2007 | 12 | 0 |
| 2008 | 16 | 0 |
| 2009 | 18 | 0 |
| 2010 | 10 | 0 |
| 2011 | 16 | 0 |
| 2012 | 28 | 0 |
| 2013 | 22 | 0 |
| 2014 | 29 | 0 |
| 2015 | 26 | 0 |
| 2016 | 29 | 0 |
| 2017 | 34 | 0 |
| 2018 | 38 | 0 |
| 2019 | 31 | 0 |
| 2020 | 39 | 0 |
| 2021 | 32 | 0 |
| 2022 | 41 | 0 |
| 2023 | 45 | 0 |
| 2024 | 47 | 0 |
| 2025 | 59 | 1 |
| 2026 | 50 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K954678 | Pro VisionSummary page 1…42 Fax : 4972 - 9 - 7482411 Name of the Device: Software updates on ProVision. Pred.icate Device : ProVision diagnostic Workstation Manufactured by Algotec Systems Ltd.(K954678). Description of the Device: The ProVision is a multi-modality diagnostic Workstation for processing and archiving radiological… | 1996 |
What descends from it? (672)
See all 6722 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
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?
ProVision is an independent diagnostic viewing and processing workstation. It is based on a Silicon Graphics Workstation running under Unix. ProVision communicates with imaging systems of different modalities (currently CT, MRI, CR, RF, NM) utilizing the DICOM - 3 standard. Connection may also be made to any other DICOM device.
ProVision functions include: Archiving, displaying, manipulation, filming, 2- and 3-dimensional processing. ProVision employs a graphical multi-Window, icon and mouse driven user interface. It is designed to ensure maxithum flexibility on the one hand, and intuitive operation on the others
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/K980648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980648: Pro Vision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980648
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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