510(k) · Cleared
ClearedRapidia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3D Med Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Sep 28, 2001 as substantially equivalent to K992654 (Voxar Limited, 1999) after a 70-day review. Its family tree reaches back 3 generations to 1996. 78 later devices descend from it.
- Decided
- Sep 28, 2001
- Review
- 70 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954678 (1996). 78 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 2 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 1 generation backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- This deviceK012290 Rapidia3D Med Co., Ltd. · 2001
- Descendant · cites it directly · 77 of its ownK021099 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
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · See all- K021099Rex, Version 1.0Pointdx, Inc. · 2002 · cites it directly77descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −2 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −1 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| 0 (this device) | K012290 | Rapidia | 3D Med Co., Ltd. | 2001 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K992654 | Plug 'N View 3D, Version 1.0 Our OCR of the scanned summary read K993654, FDA’s number for Neurocomp (Neurocybernetics). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Plug’n View 3D”. | 1999 |
What descends from it? (78)
See all 782 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 5 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K021099 (Pointdx, Inc., 2002) has gone furthest, with 77 descendants of its own.
- 15 other devices also cite its predicate K992654.
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?
Rapidia® is a software package intended for viewing and manipulating DICOM-compliant medical images from CT and MR scanners. Rapidia.® can be used for real-time viewing,
image manipulation, segmentation, 3D volume and surface rendering, virtual endoscopy,
and issuing reports.
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/K012290 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012290: Rapidia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012290
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026