510(k) · Cleared
ClearedClarity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta, Ltd. · IYE Accelerator, Linear, Medical
Cleared on Dec 5, 2012 as substantially equivalent to K111332 (Elekta, Ltd., 2012) and 2 other predicates after a 183-day review. Its family tree reaches back 9 generations to 1996. 4 of the 88 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Dec 5, 2012
- Review
- 183 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K954874 (1996). 86 ancestors in all, the oldest K851659 (1985). 1 later device descends from it, 1 citing it directly. 4 of the 88 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 5 generations between
- 3 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 2 generations backK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- 1 generation backK111332 Clarity Obp SystemElekta, Ltd. · 2012
- This deviceK121663 ClarityElekta, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK141855 ClarityElekta, Ltd. · 2014
Show all 9 generations
- Root · 9 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 8 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 7 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 6 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 5 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 4 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 3 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 2 generations backK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- 1 generation backK111332 Clarity Obp SystemElekta, Ltd. · 2012
- This deviceK121663 ClarityElekta, Ltd. · 2012
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K141855ClarityElekta, Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −8 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −7 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −6 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −5 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −4 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −3 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −2 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| −1 | K111332 | Clarity Obp System | Elekta, Ltd. | 2012 | — |
| 0 (this device) | K121663 | Clarity | Elekta, Ltd. | 2012 | — |
| +1 | K141855 | Clarity | Elekta, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 1 |
| 1997 | 5 | 0 |
| 1998 | 5 | 2 |
| 1999 | 5 | 0 |
| 2000 | 6 | 1 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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.
4 devices in this family have 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 |
|---|---|---|---|
| * | K111332 | Clarity Obp SystemSummary page 1…l equivalence. Predicate Device Information Clarity® is substantially equivalent to the following legally marketed devices in the United States: o (Clarity® OBP System {K111332, Jan 30, 2012; Product Codes: IYE, IWB, KPQ) — Elekta Ltd. e Calypso® 4D Localization System (K0O60906, Jul 28, 2006 and K080726,… | 2012 |
| * | K060906 | Calypso 4D Localization SystemSummary page 3…nt positioning during treatment (i.e., intra-fractionally) is substantially equivalent to that previously cleared for marketing with the Calypso® 4D Localization System (K060906, K080726). Both devices provide 3D localization information to assist with patient positioning prior to treatment and monitor the… | 2006 |
| * | K080726 | Calypso 4D Localization SystemSummary page 1…e United States: o (Clarity® OBP System {K111332, Jan 30, 2012; Product Codes: IYE, IWB, KPQ) — Elekta Ltd. e Calypso® 4D Localization System (K0O60906, Jul 28, 2006 and K080726, May 14, 2008; Product Code IYE} — Calypso® Medical Technologies, Inc. . _intended Use / Indications for Use Clority® is indicat… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141855 | Clarity | 2014 | 0 |
Has anything in its family been recalled? (4 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.
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 2 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 17 of the 86 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K141855 (Elekta, Ltd., 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
Clarity® is indicated for use in external beam radiation therapy, to provide 3D ultrasound and hybrid imaging of soft tissue anatomy to support radiation therapy simulation and treatment planning, and to guide patient positioning prior to the delivery of treatment.
Clarity® may also be used with an Autoscan Probe for transperineal ultrasound (TPUS) imaging, to continuously monitor the motion of the prostate and to accurately guide patient positioning during the delivery of treatment (i.e., intra-fractionally).
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/K121663 · printed Nov 3, 2026
Cite this page
510(k) Report. “K121663: Clarity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K121663
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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