510(k) · Cleared
ClearedFocus Pilot Contouring Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Computerized Medical Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Apr 2, 1999 as substantially equivalent to K961160 (Base Ten Systems, Inc., 1996) and 2 other predicates after a 338-day review. Its family tree reaches back 2 generations to 1990. 1 of the 361 devices in its family, counting itself, has a Class I recall. 354 later devices descend from it.
- Decided
- Apr 2, 1999
- Review
- 338 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K896095 (1990). 6 ancestors in all. 354 later devices descend from it, 1 citing it directly. 1 of the 361 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 1 generation backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- This deviceK981535 Focus Pilot Contouring WorkstationComputerized Medical Systems, Inc. · 1999
- Descendant · cites it directly · 353 of its ownK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- Descendant · 2 generations on · 350 of its ownK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- Descendant · 3 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- Descendant · 4 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 3 generations on · 166 of its ownK062163 MimviewerMimvista Corp. · 2006
Showing 5 of 354 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…9 generations on · 2025
Most influential descendants
Showing 5 of 354 · See all- K052379Mim 3.5 (Circa)Mimvista Corp. · 2005 · cites it directly353descendants
- K060816Mim 4.0 (NeuroMimvista Corp. · 2006 · 2 generations on350descendants
- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 3 generations on287descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 4 generations on200descendants
- K062163MimviewerMimvista Corp. · 2006 · 3 generations on166descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −1 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| 0 (this device) | K981535 | Focus Pilot Contouring Workstation | Computerized Medical Systems, Inc. | 1999 | — |
| +1 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| +2 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| +3 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| +4 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +3 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 8 | 0 |
| 2013 | 6 | 0 |
| 2014 | 11 | 0 |
| 2015 | 12 | 0 |
| 2016 | 14 | 0 |
| 2017 | 17 | 0 |
| 2018 | 24 | 0 |
| 2019 | 23 | 0 |
| 2020 | 28 | 0 |
| 2021 | 25 | 0 |
| 2022 | 32 | 0 |
| 2023 | 30 | 0 |
| 2024 | 28 | 0 |
| 2025 | 39 | 1 |
| 2026 | 36 | 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K961160 | Upacs Version 1.7Summary page 1…vice Classification: Digital Image Communication System - Radiology Panel 90 LMD - Class II Substantial Equivalence: Base Ten Systems uPACS Version 1.7 PACS : System - K961160 Applicare Medical Imaging BV RadWorks Medical Imaging Software - K962699 Olicon Imaging Systems O2-Workstation Software K973959… | 1996 |
| * | K962699 | Radworks Medical Imaging SoftwareSummary page 1…l 90 LMD - Class II Substantial Equivalence: Base Ten Systems uPACS Version 1.7 PACS : System - K961160 Applicare Medical Imaging BV RadWorks Medical Imaging Software - K962699 Olicon Imaging Systems O2-Workstation Software K973959 Device Description: The FOCUS Pilot Contouring Workstation (“the CWS”) is… | 1996 |
| * | K973959 | Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview SoftwareSummary page 1…Systems uPACS Version 1.7 PACS : System - K961160 Applicare Medical Imaging BV RadWorks Medical Imaging Software - K962699 Olicon Imaging Systems O2-Workstation Software K973959 Device Description: The FOCUS Pilot Contouring Workstation (“the CWS”) is designed to be used in conjunction with the FOCUS Radi… | 1997 |
| † | K915691 | Focus RTP | 1995 |
What descends from it? (354)
See all 3541 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052379 | Mim 3.5 (Circa) | 2005 | 353 |
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 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K052379 (Mimvista Corp., 2005) has gone furthest, with 353 descendants of its own.
- 1 other device also cites its predicate K961160.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The FOCUS Pilot Contouring Workstation permit contouring of patient tumors and critical structures on images (CT slices) at a workstation remote from the FOCUS Radiation Treatment Planning System. Images are drawn from the FOCUS RTP System, contoured and then returned to the FOCUS RTP System for completion of the treatment planning activity.
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/K981535 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981535: Focus Pilot Contouring Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981535
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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