510(k) · Cleared
Cleared1717FCC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rayence Co., Ltd. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Apr 28, 2021 as substantially equivalent to K171420 (Rayence Co., Ltd., 2017) and 1 other predicate after a 27-day review. Its family tree reaches back 10 generations to 1981.
- Decided
- Apr 28, 2021
- Review
- 27 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K803130 (1981). 38 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 6 generations between
- 3 generations backK140771 Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014
- 2 generations backK141736 Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH · 2014 · Recalled
- 1 generation backK171461 SkyPlate Detector for Philips Radiography/Fluoroscopy SystemsPhilips Medical Systems Dmc GmbH · 2017
- This deviceK210985 1717FCCRayence Co., Ltd. · 2021
Show all 10 generations
- Root · 10 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 9 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 8 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 7 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 6 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 5 generations backK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
- 4 generations backK122736 DX-D Imaging PackageAgfa Healthcare N.V. · 2013
- 3 generations backK140771 Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014
- 2 generations backK141736 Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH · 2014 · Recalled
- 1 generation backK171461 SkyPlate Detector for Philips Radiography/Fluoroscopy SystemsPhilips Medical Systems Dmc GmbH · 2017
- This deviceK210985 1717FCCRayence Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −9 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −8 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −7 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −6 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −5 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
| −4 | K122736 | DX-D Imaging Package | Agfa Healthcare N.V. | 2013 | — |
| −3 | K140771 | Philips Eleva Workspot | Philips Medical Systems Dmc GmbH | 2014 | — |
| −2 | K141736 | Philips Prograde; Philips Eleva Workspot for Digital Diagnost | Philips Medical Systems Dmc GmbH | 2014 | 6 |
| −1 | K171461 | SkyPlate Detector for Philips Radiography/Fluoroscopy Systems | Philips Medical Systems Dmc GmbH | 2017 | — |
| 0 (this device) | K210985 | 1717FCC | Rayence Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K171420 | 1717SCC_127um and 1717SCC_140umSummary page 4…me : 1717SCC_127µm and 1717SCC_140µm Common Name : Digital Flat Panel X-ray Detector 510(k) Number : K171420 Regulation Number : 21 CFR 892.1680 Regulation Name : Stationary X-ray System Regulato… | 2017 |
| * | K171461 | SkyPlate Detector for Philips Radiography/Fluoroscopy SystemsSummary page 10…l Devices 8. Conclusions: In accordance with the performance outcomes, 1717FCC demonstrated equivalent or better performance compared to 1717SCC(K171420) and SkyPlate (K171461). Therefore, Rayence claims the substantial equivalency between the subject device and the predicate device in terms of diagnosti… | 2017 |
| † | K080859 | DRF 4343 | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 40 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- 17 of the 38 ancestors have a recall of any class.
- 2 other devices also cite its predicate K171420.
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. 2021, 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?
1717FCC 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210985 · printed Nov 3, 2026
Cite this page
510(k) Report. “K210985: 1717FCC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K210985
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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