510(k) · Cleared
ClearedRadiological Image Processing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
VATECH Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Aug 10, 2011 as substantially equivalent to K091364 (Oehm Und Rehbein GmbH, 2009) after a 380-day review. Its family tree reaches back 7 generations to 1990. 6 later devices descend from it.
- Decided
- Aug 10, 2011
- Review
- 380 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K896095 (1990). 9 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 5 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 4 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 3 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 2 generations backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- 1 generation backK091364 Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009
- This deviceK102078 Radiological Image Processing SystemVATECH Co., Ltd. · 2011
- Descendant · cites it directly · 5 of its ownK160579 Xmaru View V1 and Xmaru PACS, Medical Image Processing SoftwareRayence Co., Ltd. · 2016
- Descendant · 2 generations on · 2 of its ownK191188 ASHK100GLg Electronics · 2019
- Descendant · 3 generations on · 1 of its ownK212137 X-CleverLg Electronics.Inc · 2021
- Descendant · 4 generations on · 0 of its ownK233599 X-Clever (ASHK100G)Lg Electronics.Inc · 2024
- Descendant · 2 generations on · 0 of its ownK190866 XmaruView V1 (Xmaru Chiroview, Xmaru Podview)Rayence Co., Ltd. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K160579Xmaru View V1 and Xmaru PACS, Medical Image Processing SoftwareRayence Co., Ltd. · 2016 · cites it directly5descendants
- K191188ASHK100GLg Electronics · 2019 · 2 generations on2descendants
- K212137X-CleverLg Electronics.Inc · 2021 · 3 generations on1descendant
- K233599X-Clever (ASHK100G)Lg Electronics.Inc · 2024 · 4 generations on0descendants
- K190866XmaruView V1 (Xmaru Chiroview, Xmaru Podview)Rayence Co., Ltd. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −6 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −5 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −4 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −3 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −2 | K070618 | Dicompacs, Model 5 | Oehm Und Rehbein GmbH | 2007 | — |
| −1 | K091364 | Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4 | Oehm Und Rehbein GmbH | 2009 | — |
| 0 (this device) | K102078 | Radiological Image Processing System | VATECH Co., Ltd. | 2011 | — |
| +1 | K160579 | Xmaru View V1 and Xmaru PACS, Medical Image Processing Software | Rayence Co., Ltd. | 2016 | — |
| +2 | K191188 | ASHK100G | Lg Electronics | 2019 | — |
| +3 | K212137 | X-Clever | Lg Electronics.Inc | 2021 | — |
| +4 | K233599 | X-Clever (ASHK100G) | Lg Electronics.Inc | 2024 | — |
| +2 | K190866 | XmaruView V1 (Xmaru Chiroview, Xmaru Podview) | Rayence Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K091364 | Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Summary page 2…ystems. Predicate Device: Manufacturer Oehm und Rebbein GmbH. Device dicomPACS® DX-R 1.6 5 10O(k) Number K09 1364 (Decision Date - DEC 11, 2009) Substantial Equivalence: The XrnaruView VI described in this 5 10(k) has the same intended u… | 2009 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160579 | Xmaru View V1 and Xmaru PACS, Medical Image Processing Software | 2016 | 5 |
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 21 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K160579 (Rayence Co., Ltd., 2016) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K091364.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
XmaruView V I software is to make the processing and administration of medical X-ray images as efficient as possible. Functions to be carried out using XmaruView VI is, for example, but not limited to, adjustment of window leveling, rotation, zoom, and measurements. XmaruView V1 software can control X-ray generator acquisition settings. XmaruView VI is not approved for the acquisition of mammographic image data and it cannot be used to interpret…
Read the full statement (112 words)
XmaruView V I software is to make the processing and administration of medical X-ray images as efficient as possible. Functions to be carried out using XmaruView VI is, for example, but not limited to, adjustment of window leveling, rotation, zoom, and measurements. XmaruView V1 software can control X-ray generator acquisition settings. XmaruView VI is not approved for the acquisition of mammographic image data and it cannot be used to interpret mammographic image date either. Xmai-uView VI is meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data. XmaruView VI is complying with DICOM standards to assure optimum communications between network systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102078: Radiological Image Processing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102078
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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