510(k) · Cleared
ClearedClarity Obp System
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 Jan 30, 2012 as substantially equivalent to K041937 (Resonant Medical, Inc., 2004) and 2 other predicates after a 264-day review. Its family tree reaches back 8 generations to 1996. 2 later devices descend from it.
- Decided
- Jan 30, 2012
- Review
- 264 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K954874 (1996). 62 ancestors in all, the oldest K851659 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 7 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 6 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 5 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 4 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 3 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 2 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 1 generation backK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- This deviceK111332 Clarity Obp SystemElekta, Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK121663 ClarityElekta, Ltd. · 2012
- Descendant · 2 generations on · 0 of its ownK141855 ClarityElekta, Ltd. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −7 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −6 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −5 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −4 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −3 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −2 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −1 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| 0 (this device) | K111332 | Clarity Obp System | Elekta, Ltd. | 2012 | — |
| +1 | K121663 | Clarity | Elekta, Ltd. | 2012 | — |
| +2 | K141855 | Clarity | Elekta, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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.
Planning a device in IYE? 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 |
|---|---|---|---|
| * | K041937 | RestituSummary page 1…tem. Predicate Device Information The Clarity' OBP Systemn is substantially equivalent to the following legally marketed devices in the United States: * Restitu' (K041937; Nov 16, 2004; Product Codes: lYE, IWB, KPQ) - Resonant Medical Inc. * IKOEngelo"' (K083591; Dec 29, 2008; Product Code: KP… | 2004 |
| * | K083591 | Ikoengelo, Version 2Summary page 1…lowing legally marketed devices in the United States: * Restitu' (K041937; Nov 16, 2004; Product Codes: lYE, IWB, KPQ) - Resonant Medical Inc. * IKOEngelo"' (K083591; Dec 29, 2008; Product Code: KPQ) - IKOEtech, LLC * MIM 4.1 (SEASTAR) (K071964; Sep 26, 2007; Product Code LLZ) -MlMvista C… | 2008 |
| * | K071964 | Mim 4.1 (Seastar)Summary page 1…16, 2004; Product Codes: lYE, IWB, KPQ) - Resonant Medical Inc. * IKOEngelo"' (K083591; Dec 29, 2008; Product Code: KPQ) - IKOEtech, LLC * MIM 4.1 (SEASTAR) (K071964; Sep 26, 2007; Product Code LLZ) -MlMvista Corporation intended Use The Clarity"' OBP System is intended for use in external be… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121663 | Clarity | 2012 | 1 |
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 16 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 11 of the 62 ancestors have a recall of any class.
- Of its descendants, K121663 (Elekta, Ltd., 2012) has gone furthest, with 1 descendant 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?
The Clarity'" OBP System is intended for use in external beam radiation therapy, to provide 3D
ultrasound and hybrid imaging of soft-tissue anatomy to support radiation therapy simulation
and planning, and to guide patient positioning prior to the delivery of treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111332: Clarity Obp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111332
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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