510(k) · Cleared
ClearedPicker MR Workstations (Vistar,Montage and Oncall)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · LLZ System, Image Processing, Radiological
Cleared on Jul 3, 1996 as substantially equivalent to K905070 (Philips Medical Systems (Cleveland), Inc., 1991) and 1 other predicate after a 65-day review. Its family tree reaches back 1 generation to 1991. 3 later devices descend from it.
- Decided
- Jul 3, 1996
- Review
- 65 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K905070 (1991). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- This deviceK961637 Picker MR Workstations (Vistar,Montage and Oncall)Philips Medical Systems (Cleveland), Inc. · 1996
- Descendant · cites it directly · 2 of its ownK992354 SNT Image Analysis SystemSurgical Navigation Technologies, Inc. · 1999
- Descendant · 2 generations on · 1 of its ownK081797 Image Storage System, Model KSS-400Konan Medical, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK203244 CellChek 20 rcKonan Medical, Inc. · 2021
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 |
|---|---|---|---|---|---|
| −1 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| 0 (this device) | K961637 | Picker MR Workstations (Vistar,Montage and Oncall) | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| +1 | K992354 | SNT Image Analysis System | Surgical Navigation Technologies, Inc. | 1999 | — |
| +2 | K081797 | Image Storage System, Model KSS-400 | Konan Medical, Inc. | 2009 | — |
| +3 | K203244 | CellChek 20 rc | Konan Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2009 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K905070 | VistarSummary page 2…review and cine display. 4. Safety and Effectiveness The Picker MR Workstations (ViStar, Montage and OnCall) are substantially equivalent to the ViStar (K905070) and the software described with the EDGE/VISTA systems (K931544) in safety and effectiveness. The following chart has been compi… | 1991 |
| * | K931544 | 1.5T Edge and 1.0T Vista SystemsSummary page 2…ess The Picker MR Workstations (ViStar, Montage and OnCall) are substantially equivalent to the ViStar (K905070) and the software described with the EDGE/VISTA systems (K931544) in safety and effectiveness. The following chart has been compiled to demonstrate the MR Workstations’ substantial equivalence t… | 1993 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992354 | SNT Image Analysis System | 1999 | 2 |
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?
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 MR Workstations (including the ViStar, Montage and OnCall) are designed to provide fast and convenient review of DICOM compatible digital images from all six diagnostic imaging modalities (MR, CT, Nuclear Medicine, X-Ray, CR and Ultrasound) and secondary capture as well as post-processing of MR and CT images including multi planar reformatting, angiographic rendering, surface rendering, segmentation/disarticulation and cine display.
When used in conjunction with any of these diagnostic imaging modalities, the indications for use remain unchanged from those defined for that modality.
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/K961637 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961637: Picker MR Workstations (Vistar,Montage and Oncall).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961637
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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