510(k) · Cleared
ClearedScanX Swift 2.0, ScanX Swift View 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Durr Dental SE · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Feb 6, 2023 as substantially equivalent to K202633 (Dürr Dental SE, 2020) after a 25-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Feb 6, 2023
- Review
- 25 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K934949 (1994). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK934949 DigoraOrion Corporation Soredex · 1994
- 5 generations backK041050 Digora Optime (or Digora Ontime)Soredex Palodex Group OY · 2004 · Recalled
- 4 generations backK131442 Firecr Dentalimaging System3Disc Americas · 2013
- 3 generations backK160788 RIOScan (RPS500)Ray Co., Ltd. · 2016
- 2 generations backK170733 ScanX Intraoral ViewDuerr Dental AG · 2017
- 1 generation backK202633 ScanX EdgeDürr Dental SE · 2020
- This deviceK230095 ScanX Swift 2.0, ScanX Swift View 2.0Durr Dental SE · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K934949 | Digora | Orion Corporation Soredex | 1994 | — |
| −5 | K041050 | Digora Optime (or Digora Ontime) | Soredex Palodex Group OY | 2004 | 4 |
| −4 | K131442 | Firecr Dentalimaging System | 3Disc Americas | 2013 | — |
| −3 | K160788 | RIOScan (RPS500) | Ray Co., Ltd. | 2016 | — |
| −2 | K170733 | ScanX Intraoral View | Duerr Dental AG | 2017 | — |
| −1 | K202633 | ScanX Edge | Dürr Dental SE | 2020 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K202633 | ScanX EdgeSummary page 4…stem Regulatory Class: II Product Code: MUH 3. Legally Marketed Predicate Device Information: Trade/Device Name: K202633, ScanX Edge Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system… | 2020 |
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 29 years and passes through 7 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
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. 2023, 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?
The ScanX Swift 2.0 is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.
The ScanX Swift View 2.0 is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230095 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230095: ScanX Swift 2.0, ScanX Swift View 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230095
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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