510(k) · Cleared
ClearedRTIST
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mirada Solutions, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Mar 17, 2004 as substantially equivalent to K013878 (Cybermed, Inc., 2001) and 4 other predicates after an 86-day review. Its family tree reaches back 6 generations to 1996. 75 later devices descend from it.
- Decided
- Mar 17, 2004
- Review
- 86 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K954678 (1996). 13 ancestors in all, the oldest K954355 (1995). 75 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 4 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 3 generations backK012290 Rapidia3D Med Co., Ltd. · 2001
- 2 generations backK021099 Rex, Version 1.0Pointdx, Inc. · 2002
- 1 generation backK030457 Rex, Version 3.0Pointdx, Inc. · 2003
- This deviceK033955 RTISTMirada Solutions, Ltd. · 2004
- Descendant · cites it directly · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
- Descendant · 2 generations on · 37 of its ownK102687 Mirada RTMirada Medical, Ltd. · 2010
- Descendant · 3 generations on · 36 of its ownK130393 Mirada RTXMirada Medical, Ltd. · 2013
- Descendant · 4 generations on · 25 of its ownK181572 Workflow BoxMirada Medical, Ltd. · 2018
- Descendant · 2 generations on · 11 of its ownK173088 Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 75 · See all- K101228Mirada XDMirada Medical, Ltd. · 2010 · cites it directly70descendants
- K102687Mirada RTMirada Medical, Ltd. · 2010 · 2 generations on37descendants
- K130393Mirada RTXMirada Medical, Ltd. · 2013 · 3 generations on36descendants
- K181572Workflow BoxMirada Medical, Ltd. · 2018 · 4 generations on25descendants
- K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −5 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −4 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −3 | K012290 | Rapidia | 3D Med Co., Ltd. | 2001 | — |
| −2 | K021099 | Rex, Version 1.0 | Pointdx, Inc. | 2002 | — |
| −1 | K030457 | Rex, Version 3.0 | Pointdx, Inc. | 2003 | — |
| 0 (this device) | K033955 | RTIST | Mirada Solutions, Ltd. | 2004 | — |
| +1 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| +2 | K102687 | Mirada RT | Mirada Medical, Ltd. | 2010 | — |
| +3 | K130393 | Mirada RTX | Mirada Medical, Ltd. | 2013 | — |
| +4 | K181572 | Workflow Box | Mirada Medical, Ltd. | 2018 | — |
| +2 | K173088 | Vitrea Software Toshiba Package VSTP-001A | Toshibamedical Systems Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 8 | 0 |
| 2022 | 9 | 0 |
| 2023 | 8 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 9 | 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 21.5 · 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? (5)
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 |
|---|---|---|---|
| * | K013878 | Cybermed, Inc., V-WorksSummary page 3…images may be used as an element for diagnosis. Predicate Devices: 510(k) No. Trade name Manufacturer Component Applicable to K013878 Cybermed v-works. Cybermed Inc., Technological… | 2001 |
| * | K031013 | Infintt CO., LTD. Starpacs SystemSummary page 3…Cybermed v-works. Cybermed Inc., Technological characteristics K031013 Starpacs system Infintt Co., ltd. Data management. K032483 Viatronix V3D Explorer… | 2003 |
| * | K032483 | Viatronix V3D Explorer, Revision 1.2Summary page 3…characteristics K031013 Starpacs system Infintt Co., ltd. Data management. K032483 Viatronix V3D Explorer Viatronix Inc. Technological… | 2003 |
| * | K030457 | Rex, Version 3.0Summary page 3…Viatronix V3D Explorer Viatronix Inc. Technological characteristics. K030457 Rex, version 3.0 Pointdx, Inc., Technological… | 2003 |
| * | K992654 | Plug 'N View 3D, Version 1.0Summary page 3…Rex, version 3.0 Pointdx, Inc., Technological characteristics. K992654 Plug n' view 3D Voxar Ltd. Technological… | 1999 |
| † | K020546 | Fusion 7D | 2002 |
What descends from it? (75)
See all 754 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K101228 (Mirada Medical, Ltd., 2010) has gone furthest, with 70 descendants of its own.
- 2 other devices also cite its predicate K013878.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
RTist is a software application, intended to display and visualize 2D & 3D multimodality (i.e. CT, MRI, and PET) medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant medical image data within the system and/or across computer networks at distributed locations utilizing standard PC hardware. The volume and linear measurement functions are intended for evaluation and quantification of tumor measurements…
Read the full statement (136 words)
RTist is a software application, intended to display and visualize 2D & 3D multimodality (i.e. CT, MRI, and PET) medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant medical image data within the system and/or across computer networks at distributed locations utilizing standard PC hardware.
The volume and linear measurement functions are intended for evaluation and quantification of tumor measurements, location/displacement study, analysis and evaluation of both hard and soft tissues. The software also supports interactive segmentation of the region of interest (ROI), automated contouring of multi-slice ROI and labeling of 'avoidance' structure(s) during critical evaluation.
Typical users of this system are trained professionals, including but not limited to radiologists, clinicians and technicians. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033955 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033955: RTIST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033955
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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