510(k) · Cleared
ClearedRex, Version 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pointdx, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jun 27, 2002 as substantially equivalent to K012290 (3D Med Co., Ltd., 2001) after an 84-day review. Its family tree reaches back 4 generations to 1996. 77 later devices descend from it.
- Decided
- Jun 27, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954678 (1996). 77 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 3 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 2 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 1 generation backK012290 Rapidia3D Med Co., Ltd. · 2001
- This deviceK021099 Rex, Version 1.0Pointdx, Inc. · 2002
- Descendant · cites it directly · 76 of its ownK030457 Rex, Version 3.0Pointdx, Inc. · 2003
- Descendant · 2 generations on · 75 of its ownK033955 RTISTMirada Solutions, Ltd. · 2004
- Descendant · 3 generations on · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
- Descendant · 4 generations on · 37 of its ownK102687 Mirada RTMirada Medical, Ltd. · 2010
- Descendant · 5 generations on · 36 of its ownK130393 Mirada RTXMirada Medical, Ltd. · 2013
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · See all- K030457Rex, Version 3.0Pointdx, Inc. · 2003 · cites it directly76descendants
- K033955RTISTMirada Solutions, Ltd. · 2004 · 2 generations on75descendants
- K101228Mirada XDMirada Medical, Ltd. · 2010 · 3 generations on70descendants
- K102687Mirada RTMirada Medical, Ltd. · 2010 · 4 generations on37descendants
- K130393Mirada RTXMirada Medical, Ltd. · 2013 · 5 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −3 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −2 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −1 | K012290 | Rapidia | 3D Med Co., Ltd. | 2001 | — |
| 0 (this device) | K021099 | Rex, Version 1.0 | Pointdx, Inc. | 2002 | — |
| +1 | K030457 | Rex, Version 3.0 | Pointdx, Inc. | 2003 | — |
| +2 | K033955 | RTIST | Mirada Solutions, Ltd. | 2004 | — |
| +3 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| +4 | K102687 | Mirada RT | Mirada Medical, Ltd. | 2010 | — |
| +5 | K130393 | Mirada RTX | Mirada Medical, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K012290 | Rapidia | 2001 |
What descends from it? (77)
See all 771 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030457 | Rex, Version 3.0 | 2003 | 76 |
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 6 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K030457 (Pointdx, Inc., 2003) has gone furthest, with 76 descendants of its own.
- 1 other device also cites its predicate K012290.
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?
REXTM1.0 is a software package intended for viewing and manipulating DICOM-compliant medical images acquired from CT scanners. REXTM1.O can be used for real-time image viewing, image manipulation, 3D volume rendering, virtual endoscopy, and issuance of reports.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021099 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021099: Rex, Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021099
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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