510(k) · Cleared
ClearedVivix-S 1717V
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 15, 2018 as substantially equivalent to K152894 (Vieworks Co., Ltd., 2016) after a 29-day review. Its family tree reaches back 8 generations to 1981. 7 later devices descend from it.
- Decided
- May 15, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K803130 (1981). 26 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 7 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 5 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 4 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 3 generations backK120020 Vivix-SVieworks Co., Ltd. · 2012
- 2 generations backK122866 Vivix-S with VxvueVieworks Co., Ltd. · 2013
- 1 generation backK152894 Vivix-S 1717NVieworks Co., Ltd. · 2016
- This deviceK181003 Vivix-S 1717VVieworks Co., Ltd. · 2018
- Descendant · cites it directly · 4 of its ownK200418 Vivix-S VWVieworks Co., Ltd. · 2020
- Descendant · 2 generations on · 2 of its ownK221512 Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)Vieworks Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK241980 !M1Solutions For Tomorrow AB · 2025
- Descendant · cites it directly · 1 of its ownK220239 Solid State X-ray Imager (Model: FXRD-4386WB)Vieworks Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK260820 Vivix-S 4386W (FXRD-4386WA)Vieworks Co., Ltd. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K200418Vivix-S VWVieworks Co., Ltd. · 2020 · cites it directly4descendants
- K221512Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)Vieworks Co., Ltd. · 2022 · 2 generations on2descendants
- K241980!M1Solutions For Tomorrow AB · 2025 · 2 generations on1descendant
- K220239Solid State X-ray Imager (Model: FXRD-4386WB)Vieworks Co., Ltd. · 2022 · cites it directly1descendant
- K260820Vivix-S 4386W (FXRD-4386WA)Vieworks Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −7 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −6 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −5 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −4 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −3 | K120020 | Vivix-S | Vieworks Co., Ltd. | 2012 | — |
| −2 | K122866 | Vivix-S with Vxvue | Vieworks Co., Ltd. | 2013 | — |
| −1 | K152894 | Vivix-S 1717N | Vieworks Co., Ltd. | 2016 | — |
| 0 (this device) | K181003 | Vivix-S 1717V | Vieworks Co., Ltd. | 2018 | — |
| +1 | K200418 | Vivix-S VW | Vieworks Co., Ltd. | 2020 | — |
| +2 | K221512 | Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) | Vieworks Co., Ltd. | 2022 | — |
| +2 | K241980 | !M1 | Solutions For Tomorrow AB | 2025 | — |
| +1 | K220239 | Solid State X-ray Imager (Model: FXRD-4386WB) | Vieworks Co., Ltd. | 2022 | — |
| +2 | K260820 | Vivix-S 4386W (FXRD-4386WA) | Vieworks Co., Ltd. | 2026 | — |
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 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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? (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 |
|---|---|---|---|
| * | K152894 | Vivix-S 1717NSummary page 4…Product Code: MQB Device Class: 2 4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)] 510(k) Number: K152894 Product Code: MQB Applicant: Vieworks Co., Ltd. Trade Name: VIVI… | 2016 |
What descends from it? (7)
2 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 37 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 10 of the 26 ancestors have a recall of any class.
- Of its descendants, K200418 (Vieworks Co., Ltd., 2020) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K152894.
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. 2018, 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 1717V series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S 1717V series is not intended for mammography applications.
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/K181003 · printed Nov 4, 2026
Cite this page
510(k) Report. “K181003: Vivix-S 1717V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K181003
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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