510(k) · Cleared
ClearedOpal-Rad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viztek, Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 12, 2006 as substantially equivalent to K032176 (Rattan Information Corporation, 2003) after a 36-day review. Its family tree reaches back 3 generations to 2001. 45 later devices descend from it.
- Decided
- Dec 12, 2006
- Review
- 36 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010259 (2001). 45 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK010259 Mediface PacsMediface Co., Ltd. · 2001
- 2 generations backK012844 Marosis PacsMarotech, Inc. · 2001
- 1 generation backK032176 Rattan Imacs by Rattan Information CorporationRattan Information Corporation · 2003
- This deviceK063337 Opal-RadViztek, Inc. · 2006
- Descendant · cites it directly · 36 of its ownK102123 Vizion DRViztek, Inc. · 2011
- Descendant · 2 generations on · 34 of its ownK112661 Vizion DRViztek, LLC · 2011
- Descendant · 3 generations on · 33 of its ownK123644 Vizion + DRViztek, LLC · 2013
- Descendant · 4 generations on · 27 of its ownK152279 ViZion DR + WirelessViztek, LLC · 2015
- Descendant · 5 generations on · 24 of its ownK161730 Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd. · 2016
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K102123Vizion DRViztek, Inc. · 2011 · cites it directly36descendants
- K112661Vizion DRViztek, LLC · 2011 · 2 generations on34descendants
- K123644Vizion + DRViztek, LLC · 2013 · 3 generations on33descendants
- K152279ViZion DR + WirelessViztek, LLC · 2015 · 4 generations on27descendants
- K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd. · 2016 · 5 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010259 | Mediface Pacs | Mediface Co., Ltd. | 2001 | — |
| −2 | K012844 | Marosis Pacs | Marotech, Inc. | 2001 | — |
| −1 | K032176 | Rattan Imacs by Rattan Information Corporation | Rattan Information Corporation | 2003 | — |
| 0 (this device) | K063337 | Opal-Rad | Viztek, Inc. | 2006 | — |
| +1 | K102123 | Vizion DR | Viztek, Inc. | 2011 | — |
| +2 | K112661 | Vizion DR | Viztek, LLC | 2011 | — |
| +3 | K123644 | Vizion + DR | Viztek, LLC | 2013 | — |
| +4 | K152279 | ViZion DR + Wireless | Viztek, LLC | 2015 | — |
| +5 | K161730 | Wireless Digital Flat Panel Detector | Iray Technology (Shanghai), Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K032176 | Rattan Imacs by Rattan Information CorporationSummary page 1…050 Classification Name: System, Image Processing Predicate Device: 21 CFR 807. 92(a)(3) Opal-RADr m is substantially equivalent to: 510(k) Number K032176 Regulation Number 892.2050 NameRATTAN IMACS BY RATTAN INFORMATION Device Devic… | 2003 |
What descends from it? (45)
See all 455 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 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K102123 (Viztek, Inc., 2011) has gone furthest, with 36 descendants of its own.
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?
Opal-RADTM is a software 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. Lossy compressed mammographic images…
Read the full statement (108 words)
Opal-RADTM is a software 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. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used.
Typical users of this system are trained professionals, nurses, and technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063337: Opal-Rad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063337
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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