510(k) · Cleared
ClearedSimplicit90Y
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mirada Medical, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Dec 6, 2018 as substantially equivalent to K172218 (Mim Software, Inc., 2017) after a 132-day review. Its family tree reaches back 12 generations to 1996. 3 later devices descend from it.
- Decided
- Dec 6, 2018
- Review
- 132 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K954874 (1996). 62 ancestors in all, the oldest K885054 (1989). 3 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 8 generations between
- 3 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 2 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 1 generation backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- This deviceK182016 Simplicit90YMirada Medical, Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK252547 TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation · 2025 · Recalled
- Descendant · 2 generations on · 1 of its ownK260479 TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation · 2026 · Recalled
- Descendant · 3 generations on · 0 of its ownK262462 TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation · 2026
Show all 12 generations
- Root · 12 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 11 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 10 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 9 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 8 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 7 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 6 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 5 generations backK062163 MimviewerMimvista Corp. · 2006
- 4 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 3 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 2 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 1 generation backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- This deviceK182016 Simplicit90YMirada Medical, Ltd. · 2018
Most influential descendants
Showing 3 of 3 · See all- K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation · 2025 · cites it directly2descendants
- K260479TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation · 2026 · 2 generations on1descendant
- K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −11 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −10 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −9 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −8 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −7 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −6 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −5 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −4 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −3 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −2 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| −1 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| 0 (this device) | K182016 | Simplicit90Y | Mirada Medical, Ltd. | 2018 | — |
| +1 | K252547 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2025 | 1 |
| +2 | K260479 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2026 | 1 |
| +3 | K262462 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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.
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 21.6 · 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? (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 |
|---|---|---|---|
| * | K172218 | MIM – Y90 DosimetrySummary page 5…(892.2050) Product Code: LLZ Predicate Device 510(k) Number Trade Name Manufacturer K172218 MIM – Y90 Dosimetry MIM Software Inc. Reference Devices 510(k) Number Trade Name… | 2017 |
| † | K102687 | Mirada RT | 2010 |
| † | K130393 | Mirada RTX | 2013 |
| † | K101228 | Mirada XD | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252547 | TheraSphere 360™ Y-90 Management Platform | 2025 | 2 |
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 22 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 13 of the 62 ancestors have a recall of any class.
- Of its descendants, K252547 (Boston Scientific Corporation, 2025) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K172218.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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?
Simplicit90Y is a standalone software device that is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. Simplicit90Y supports the reading, rendering and display of a range of DICOM compliant imaging and related formats including but not limited to CT, PT, NM, SPECT, MR, SC, RTSS. Simplicit90Y enables the saving of sessions in a proprietary format as well as the export of formats…
Read the full statement (282 words)
Simplicit90Y is a standalone software device that is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images.
Simplicit90Y supports the reading, rendering and display of a range of DICOM compliant imaging and related formats including but not limited to CT, PT, NM, SPECT, MR, SC, RTSS. Simplicit90Y enables the saving of sessions in a proprietary format as well as the export of formats including CSV and PDF files.
Simplicit90Y is indicated, as an accessory to TheraSphere®, to provide pre-treatment dosimetry planning support including Lung Shunt Fraction estimation (based on planar scintigraphy) and liver single-compartment MIRD schema dosimetry, in accordance with TheraSphere® labelling. Simplicit90Y provides tools to create, transform, and modify contours/Regions of Interest for calculation of Lung Shunt Fraction and Perfused Volume. Simplicit90Y includes features to aid in TheraSphere® dose vial selection, dose vial ordering and creation of customizable reports.
Simplicit90Y is indicated for post-treatment dosimetry and evaluation following Yttrium-90 (Y-90) microsphere treatment. Simplicit90Y provides tools to create, transform, and modify contours/Regions of Interest for the user to define objects in medical image volumes to support TheraSphere® post-Y-90 treatment calculation and evaluation. The objects include, but are not limited to, tumors and normal tissues, and liver volumes.
Simplicit90Y is indicated for registration, fusion display and review of medical images allowing medical professionals to incorporate images, such as CT, MRI, PET, CBCT and SPECT in TheraSphere® Yttrium-90 (Y-90) microspheres pre-treatment planning and post-Y-90 treatment evaluation.
For post-Yttrium-90 (Y-90) treatment, Simplicit90Y should only be used for the retrospective determination of dose and should not be used to prospectively calculate dose or for the case where there is a need for retreatment using Y-90 microspheres.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182016 · printed Nov 3, 2026
Cite this page
510(k) Report. “K182016: Simplicit90Y.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K182016
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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