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 Oct 8, 2014 as substantially equivalent to K121663 (Elekta, Ltd., 2012) after a 91-day review. Its family tree reaches back 10 generations to 1996. 4 of the 88 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 8, 2014
- Review
- 91 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K954874 (1996). 87 ancestors in all, the oldest K851659 (1985). No later device cites it as a predicate yet. 4 of the 88 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 6 generations between
- 3 generations backK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- 2 generations backK111332 Clarity Obp SystemElekta, Ltd. · 2012
- 1 generation backK121663 ClarityElekta, Ltd. · 2012
- This deviceK141855 ClarityElekta, Ltd. · 2014
Show all 10 generations
- Root · 10 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 9 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 8 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 7 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 6 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 5 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 4 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 3 generations backK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- 2 generations backK111332 Clarity Obp SystemElekta, Ltd. · 2012
- 1 generation backK121663 ClarityElekta, Ltd. · 2012
- This deviceK141855 ClarityElekta, Ltd. · 2014
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −9 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −8 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −7 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −6 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −5 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −4 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −3 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| −2 | K111332 | Clarity Obp System | Elekta, Ltd. | 2012 | — |
| −1 | K121663 | Clarity | Elekta, Ltd. | 2012 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K121663 | ClaritySummary page 4…ice safety and effectiveness information to provide an understanding of the basis for a determination of substantial equivalence. Predicate Device Information Clarity® (K 121663, Dec 05, 2012; Product Codes: IYE, IWB, KPQ) Intended Use / Indications for Use Clarity® is indicated for use in external beam… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 3 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 17 of the 87 ancestors have a recall of any class; 4 have a Class I recall.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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. It provides 3D ultrasound and hybrid imaging of soft tissue anatomy to aid in radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment (Image Guided Radiation Therapy). When configured with an autoscan probe kit for transperineal ultrasound (TPUS) imaging, Clarity® may be used to continuously track and monitor the motion of the prostate…
Read the full statement (183 words)
Clarity® is indicated for use in external beam radiation therapy. It provides 3D ultrasound and hybrid imaging of soft tissue anatomy to aid in radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment (Image Guided Radiation Therapy).
When configured with an autoscan probe kit for transperineal ultrasound (TPUS) imaging, Clarity® may be used to continuously track and monitor the motion of the prostate and to accurately and precisely guide patient positioning during the delivery of treatment (Intrafractional Position Tracking and Monitoring).
When configured with a gating option, Clarity® may also interface with radiation delivery systems equipped with a compatible external gating control device. With this option, while in tracking and monitoring mode, Clarity® can signal the radiation delivery system to automatically impose a beam-hold when the position of the tracked anatomy has exceeded pre-defined monitoring (tracking) limits, and signal again to release the beam-hold when the tracked anatomy returns to a position within those limits (Exception Gating). Exception gating has been shown to be compatible with radiation delivery systems equipped with Elekta’s Response™ Gating Control System.
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/K141855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141855: Clarity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141855
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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