510(k) · Cleared
ClearedRattan Imacs by Rattan Information Corporation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rattan Information Corporation · LLZ System, Image Processing, Radiological
Cleared on Sep 25, 2003 as substantially equivalent to K012844 (Marotech, Inc., 2001) after a 71-day review. Its family tree reaches back 2 generations to 2001. 46 later devices descend from it.
- Decided
- Sep 25, 2003
- Review
- 71 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010259 (2001). 46 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK010259 Mediface PacsMediface Co., Ltd. · 2001
- 1 generation backK012844 Marosis PacsMarotech, Inc. · 2001
- This deviceK032176 Rattan Imacs by Rattan Information CorporationRattan Information Corporation · 2003
- Descendant · cites it directly · 45 of its ownK063337 Opal-RadViztek, Inc. · 2006
- Descendant · 2 generations on · 36 of its ownK102123 Vizion DRViztek, Inc. · 2011
- Descendant · 3 generations on · 34 of its ownK112661 Vizion DRViztek, LLC · 2011
- Descendant · 4 generations on · 33 of its ownK123644 Vizion + DRViztek, LLC · 2013
- Descendant · 5 generations on · 27 of its ownK152279 ViZion DR + WirelessViztek, LLC · 2015
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K063337Opal-RadViztek, Inc. · 2006 · cites it directly45descendants
- K102123Vizion DRViztek, Inc. · 2011 · 2 generations on36descendants
- K112661Vizion DRViztek, LLC · 2011 · 3 generations on34descendants
- K123644Vizion + DRViztek, LLC · 2013 · 4 generations on33descendants
- K152279ViZion DR + WirelessViztek, LLC · 2015 · 5 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010259 | Mediface Pacs | Mediface Co., Ltd. | 2001 | — |
| −1 | K012844 | Marosis Pacs | Marotech, Inc. | 2001 | — |
| 0 (this device) | K032176 | Rattan Imacs by Rattan Information Corporation | Rattan Information Corporation | 2003 | — |
| +1 | K063337 | Opal-Rad | Viztek, Inc. | 2006 | — |
| +2 | K102123 | Vizion DR | Viztek, Inc. | 2011 | — |
| +3 | K112661 | Vizion DR | Viztek, LLC | 2011 | — |
| +4 | K123644 | Vizion + DR | Viztek, LLC | 2013 | — |
| +5 | K152279 | ViZion DR + Wireless | Viztek, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 3 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K012844 | Marosis Pacs | 2001 |
What descends from it? (46)
See all 461 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063337 | Opal-Rad | 2006 | 45 |
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 2 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K063337 (Viztek, Inc., 2006) has gone furthest, with 45 descendants of its own.
- 3 other devices also cite its predicate K012844.
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?
The RATTAN IMACS'\I system is a device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, nurses, and technicians
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032176: Rattan Imacs by Rattan Information Corporation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032176
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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