510(k) · Cleared
ClearedModification to: Viewstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Impac Medical Systems, Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 20, 2004 as substantially equivalent to K011694 (Impac Medical Systems, Inc., 2001) and 1 other predicate after a 10-day review. Its family tree reaches back 2 generations to 1995. 9 later devices descend from it.
- Decided
- Dec 20, 2004
- Review
- 10 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K942346 (1995). 9 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK942346 ImagertImpac Medical Systems, Inc. · 1995
- 1 generation backK011694 ViewstationImpac Medical Systems, Inc. · 2001
- This deviceK043412 Modification to: ViewstationImpac Medical Systems, Inc. · 2004
- Descendant · cites it directly · 8 of its ownK120067 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 5 of its ownK142142 Quality ReportsSun Nuclear Corporation · 2014
- Descendant · 3 generations on · 4 of its ownK162468 ClearCheckRadformation · 2016
- Descendant · 4 generations on · 3 of its ownK220583 ClearCheck Model RADCC V2Radformation, Inc. · 2022
- Descendant · 5 generations on · 1 of its ownK231185 MapRTVision Rt, Ltd. · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K120067Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012 · cites it directly8descendants
- K142142Quality ReportsSun Nuclear Corporation · 2014 · 2 generations on5descendants
- K162468ClearCheckRadformation · 2016 · 3 generations on4descendants
- K220583ClearCheck Model RADCC V2Radformation, Inc. · 2022 · 4 generations on3descendants
- K231185MapRTVision Rt, Ltd. · 2023 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942346 | Imagert | Impac Medical Systems, Inc. | 1995 | — |
| −1 | K011694 | Viewstation | Impac Medical Systems, Inc. | 2001 | — |
| 0 (this device) | K043412 | Modification to: Viewstation | Impac Medical Systems, Inc. | 2004 | — |
| +1 | K120067 | Mosaiq Oncology Information System | Impac Medical Systems, Inc. | 2012 | 3 |
| +2 | K142142 | Quality Reports | Sun Nuclear Corporation | 2014 | — |
| +3 | K162468 | ClearCheck | Radformation | 2016 | — |
| +4 | K220583 | ClearCheck Model RADCC V2 | Radformation, Inc. | 2022 | — |
| +5 | K231185 | MapRT | Vision Rt, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K011694 | ViewstationSummary page 2…substantially equivalent to the original ViewStation product, which is currently marketed by IMPAC Medical Systems, Inc., and was the subject of Premarket Notifications K01 1694 and K942346. The new ViewStation and previous ViewStation products are equivalent in intended use and safety and effectiveness.… | 2001 |
| * | K942346 | ImagertSummary page 1…resentative listed below. Premarket Notification Information I1. Previous Notification Information: a. Previous Premarket Notification 4 KG 11694, K 942346 b. Previous Submission Date 05/31/01, 05/16/94 c. Previous FDA Clearance Date… | 1995 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120067 | Mosaiq Oncology Information System | 2012 | 8 |
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 9 years and passes through 1 company; a new generation was cleared every 6.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K120067 (Impac Medical Systems, Inc., 2012) has gone furthest, with 8 descendants 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.
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?
ViewStation supports image and information flow among health care facility personnel. ViewStation can be used whenever digital images and associated data are the means for communicating information. ViewStation is not intended for use in diagnosis.
The intended use of ViewStation is to provide health care facility personnel with an efficient and effective means to utilize patient images during the course of therapy or treatment. ViewStation allows users to import, view, annotate, manipulate, enhance, manage, and archive patient images. The images and associated information are stored in a database, providing users access to the information necessary to perform their functions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043412: Modification to: Viewstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043412
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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