510(k) · Cleared
ClearedRIOScan (RPS500)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ray Co., Ltd. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Apr 15, 2016 as substantially equivalent to K133231 (Instrumentarium Dental, Palodex Group OY, 2014) and 1 other predicate after a 24-day review. Its family tree reaches back 3 generations to 1994. 6 later devices descend from it.
- Decided
- Apr 15, 2016
- Review
- 24 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K934949 (1994). 4 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK934949 DigoraOrion Corporation Soredex · 1994
- 2 generations backK041050 Digora Optime (or Digora Ontime)Soredex Palodex Group OY · 2004 · Recalled
- 1 generation backK131442 Firecr Dentalimaging System3Disc Americas · 2013
- This deviceK160788 RIOScan (RPS500)Ray Co., Ltd. · 2016
- Descendant · cites it directly · 5 of its ownK170733 ScanX Intraoral ViewDuerr Dental AG · 2017
- Descendant · 2 generations on · 1 of its ownK212080 Imaging Plate Scanner, i-ScanGuilin Woodpecker Medical Instrument Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK202633 ScanX EdgeDürr Dental SE · 2020
- Descendant · 3 generations on · 0 of its ownK231660 Digital image scanner of dentalJiangsu Dynamic Medical Technology Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK230095 ScanX Swift 2.0, ScanX Swift View 2.0Durr Dental SE · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K170733ScanX Intraoral ViewDuerr Dental AG · 2017 · cites it directly5descendants
- K212080Imaging Plate Scanner, i-ScanGuilin Woodpecker Medical Instrument Co., Ltd. · 2021 · 2 generations on1descendant
- K202633ScanX EdgeDürr Dental SE · 2020 · 2 generations on1descendant
- K231660Digital image scanner of dentalJiangsu Dynamic Medical Technology Co., Ltd. · 2023 · 3 generations on0descendants
- K230095ScanX Swift 2.0, ScanX Swift View 2.0Durr Dental SE · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934949 | Digora | Orion Corporation Soredex | 1994 | — |
| −2 | K041050 | Digora Optime (or Digora Ontime) | Soredex Palodex Group OY | 2004 | 4 |
| −1 | K131442 | Firecr Dentalimaging System | 3Disc Americas | 2013 | — |
| 0 (this device) | K160788 | RIOScan (RPS500) | Ray Co., Ltd. | 2016 | — |
| +1 | K170733 | ScanX Intraoral View | Duerr Dental AG | 2017 | — |
| +2 | K212080 | Imaging Plate Scanner, i-Scan | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021 | — |
| +2 | K202633 | ScanX Edge | Dürr Dental SE | 2020 | — |
| +3 | K231660 | Digital image scanner of dental | Jiangsu Dynamic Medical Technology Co., Ltd. | 2023 | — |
| +3 | K230095 | ScanX Swift 2.0, ScanX Swift View 2.0 | Durr Dental SE | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 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 MUH? 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 MUH device
- #1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 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 |
|---|---|---|---|
| * | K133231 | Digora OptimeSummary page 5…ges. Predicate device 1) Predicate device-1 Manufacturer: PaloDEx Group Oy Device: DIGORA Optime (DXR-60) 510(k) Number: K133231 2) Predicate device-2 Manufacturer: 3D Imaging & Simulations Corp Device: FireCR Dental Imaging SYste… | 2014 |
| * | K131442 | Firecr Dentalimaging SystemSummary page 5…mber: K133231 2) Predicate device-2 Manufacturer: 3D Imaging & Simulations Corp Device: FireCR Dental Imaging SYstem 510(k) Number: K131442 Statement of Substantial Equivalence Parameter Proposed Device Predicated Device Pr… | 2013 |
| † | K143000 | RIS500 | 2015 |
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 |
|---|---|---|---|
| K170733 | ScanX Intraoral View | 2017 | 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 22 years and passes through 4 companies; a new generation was cleared every 9.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K170733 (Duerr Dental AG, 2017) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K133231.
How does its category compare?
All MUH devicesMUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MUH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUH
159in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUH
1in 2025
MAUDE reports naming product code MUH, 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 | 11 | 48 | 0 | 0 |
| 2008 | 8 | 64 | 1 | 0 |
| 2009 | 9 | 88 | 2 | 12 |
| 2010 | 9 | 174 | 0 | 9 |
| 2011 | 10 | 89 | 0 | 0 |
| 2012 | 9 | 81 | 0 | 5 |
| 2013 | 9 | 172 | 1 | 1 |
| 2014 | 8 | 168 | 1 | 5 |
| 2015 | 12 | 111 | 1 | 3 |
| 2016 | 6 | 47 | 0 | 1 |
| 2017 | 9 | 84 | 0 | 4 |
| 2018 | 3 | 29 | 0 | 10 |
| 2019 | 5 | 64 | 0 | 6 |
| 2020 | 5 | 36 | 0 | 0 |
| 2021 | 10 | 80 | 0 | 1 |
| 2022 | 7 | 57 | 0 | 0 |
| 2023 | 11 | 57 | 0 | 1 |
| 2024 | 4 | 144 | 0 | 0 |
| 2025 | 3 | 159 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
This system is a digital intraoral dental radiographic imaging system intended for use by dentists and dental subspecialists. The system captures, digitizes, displays and sores diagnostic intraoral radiographic images.
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/K160788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160788: RIOScan (RPS500).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160788
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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