510(k) · Cleared
ClearedDigora Optime
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentarium Dental, Palodex Group OY · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Mar 20, 2014 as substantially equivalent to K041050 (Soredex Palodex Group OY, 2004) after a 150-day review. Its family tree reaches back 2 generations to 1994. 9 later devices descend from it.
- Decided
- Mar 20, 2014
- Review
- 150 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K934949 (1994). 9 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK934949 DigoraOrion Corporation Soredex · 1994
- 1 generation backK041050 Digora Optime (or Digora Ontime)Soredex Palodex Group OY · 2004 · Recalled
- This deviceK133231 Digora OptimeInstrumentarium Dental, Palodex Group OY · 2014
- Descendant · cites it directly · 6 of its ownK160788 RIOScan (RPS500)Ray Co., Ltd. · 2016
- Descendant · 2 generations on · 5 of its ownK170733 ScanX Intraoral ViewDuerr Dental AG · 2017
- Descendant · 3 generations on · 1 of its ownK212080 Imaging Plate Scanner, i-ScanGuilin Woodpecker Medical Instrument Co., Ltd. · 2021
- Descendant · 3 generations on · 1 of its ownK202633 ScanX EdgeDürr Dental SE · 2020
- Descendant · cites it directly · 1 of its ownK183637 Cruxcan (CRX-1000)Cruxell Corp. · 2019
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K160788RIOScan (RPS500)Ray Co., Ltd. · 2016 · cites it directly6descendants
- K170733ScanX Intraoral ViewDuerr Dental AG · 2017 · 2 generations on5descendants
- K212080Imaging Plate Scanner, i-ScanGuilin Woodpecker Medical Instrument Co., Ltd. · 2021 · 3 generations on1descendant
- K202633ScanX EdgeDürr Dental SE · 2020 · 3 generations on1descendant
- K183637Cruxcan (CRX-1000)Cruxell Corp. · 2019 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934949 | Digora | Orion Corporation Soredex | 1994 | — |
| −1 | K041050 | Digora Optime (or Digora Ontime) | Soredex Palodex Group OY | 2004 | 4 |
| 0 (this device) | K133231 | Digora Optime | Instrumentarium Dental, Palodex Group OY | 2014 | — |
| +1 | K160788 | RIOScan (RPS500) | Ray Co., Ltd. | 2016 | — |
| +2 | K170733 | ScanX Intraoral View | Duerr Dental AG | 2017 | — |
| +3 | K212080 | Imaging Plate Scanner, i-Scan | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021 | — |
| +3 | K202633 | ScanX Edge | Dürr Dental SE | 2020 | — |
| +1 | K183637 | Cruxcan (CRX-1000) | Cruxell Corp. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 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 |
|---|---|---|---|
| * | K041050 | Digora Optime (or Digora Ontime)Summary page 4…sed upon the similar technological/performance characteristics to the predicate device and the successful validation of the DIGORA Optime (K041050), the clinical performance w~wp~odugsup~o~n of the DIGORA® Optime (DXR-60) is deemed to be substantially equivalent… | 2004 |
What descends from it? (9)
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 20 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K160788 (Ray Co., Ltd., 2016) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K041050.
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. 2014, 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 DIGORA® Optime imaging system is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133231: Digora Optime.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133231
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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