510(k) · Cleared
ClearedVivix-S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vieworks Co., Ltd. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on May 4, 2012 as substantially equivalent to K024147 (Varian Medical Systems, Inc., 2003) and 1 other predicate after a 122-day review. Its family tree reaches back 5 generations to 1981. 30 later devices descend from it.
- Decided
- May 4, 2012
- Review
- 122 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K803130 (1981). 22 ancestors in all. 30 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 4 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 3 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 2 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 1 generation backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- This deviceK120020 Vivix-SVieworks Co., Ltd. · 2012
- Descendant · cites it directly · 28 of its ownK122865 Vivix-S WirelessVieworks Co., Ltd. · 2013
- Descendant · 2 generations on · 12 of its ownK150929 CareView 1500Cw X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. · 2015
- Descendant · cites it directly · 11 of its ownK122866 Vivix-S with VxvueVieworks Co., Ltd. · 2013
- Descendant · 2 generations on · 9 of its ownK152894 Vivix-S 1717NVieworks Co., Ltd. · 2016
- Descendant · 3 generations on · 8 of its ownK153058 CareView 1500C/ CareView 1500L X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. · 2015
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K122865Vivix-S WirelessVieworks Co., Ltd. · 2013 · cites it directly28descendants
- K150929CareView 1500Cw X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. · 2015 · 2 generations on12descendants
- K122866Vivix-S with VxvueVieworks Co., Ltd. · 2013 · cites it directly11descendants
- K152894Vivix-S 1717NVieworks Co., Ltd. · 2016 · 2 generations on9descendants
- K153058CareView 1500C/ CareView 1500L X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. · 2015 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −4 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −3 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −2 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −1 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| 0 (this device) | K120020 | Vivix-S | Vieworks Co., Ltd. | 2012 | — |
| +1 | K122865 | Vivix-S Wireless | Vieworks Co., Ltd. | 2013 | — |
| +2 | K150929 | CareView 1500Cw X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | 2015 | — |
| +1 | K122866 | Vivix-S with Vxvue | Vieworks Co., Ltd. | 2013 | — |
| +2 | K152894 | Vivix-S 1717N | Vieworks Co., Ltd. | 2016 | — |
| +3 | K153058 | CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 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 MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K024147 | Paxscan 4030 Medical Digital Imaging SystemSummary page 2…de :MQB Vieworks Co., Ltd. 510(k) Submission - ViVIX-S Device Class .2 510(k) Number K024147 Manufacturer Samsung Mobile Display Co., Ltd. Trade/ Proprietary Name LTX-240AA01 -A… | 2003 |
| * | K090742 | Digital Flat Panel X-Ray Detector, Model LTX240AA01-aSummary page 2…ification Name Solid State X-ray Imager Product Code MQB Device Class .2 510(k) Number :K090742 Description: ViVIX-S is a digital X-ray flat panel detector which has 43x43cm (FXRD-1717SA, FXRD-1 71 7S8) or 35.8x4… | 2009 |
What descends from it? (30)
See all 302 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 31 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 10 of the 22 ancestors have a recall of any class.
- Of its descendants, K122865 (Vieworks Co., Ltd., 2013) has gone furthest, with 28 descendants of its own.
- 5 other devices also cite its predicate K024147.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
ViVIX-S is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography and/or for fluoroscopy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120020 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120020: Vivix-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120020
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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