510(k) · Cleared
Recalled · Class II · 2020Digora Optime (or Digora Ontime)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Soredex Palodex Group OY · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Jun 15, 2004 as substantially equivalent to K934949 (Orion Corporation Soredex, 1994) after a 54-day review. Its family tree reaches back 1 generation to 1994. 14 later devices descend from it. It has been recalled 4 times.
- Decided
- Jun 15, 2004
- Review
- 54 days
- Class
- Class II
- Product code
- MUH
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934949 (1994). 14 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK934949 DigoraOrion Corporation Soredex · 1994
- This deviceK041050 Digora Optime (or Digora Ontime)Soredex Palodex Group OY · 2004
- Descendant · cites it directly · 9 of its ownK133231 Digora OptimeInstrumentarium Dental, Palodex Group OY · 2014
- Descendant · cites it directly · 9 of its ownK131442 Firecr Dentalimaging System3Disc Americas · 2013
- Descendant · 2 generations on · 6 of its ownK160788 RIOScan (RPS500)Ray Co., Ltd. · 2016
- Descendant · 3 generations on · 5 of its ownK170733 ScanX Intraoral ViewDuerr Dental AG · 2017
- Descendant · 4 generations on · 1 of its ownK212080 Imaging Plate Scanner, i-ScanGuilin Woodpecker Medical Instrument Co., Ltd. · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K133231Digora OptimeInstrumentarium Dental, Palodex Group OY · 2014 · cites it directly9descendants
- K131442Firecr Dentalimaging System3Disc Americas · 2013 · cites it directly9descendants
- K160788RIOScan (RPS500)Ray Co., Ltd. · 2016 · 2 generations on6descendants
- K170733ScanX Intraoral ViewDuerr Dental AG · 2017 · 3 generations on5descendants
- K212080Imaging Plate Scanner, i-ScanGuilin Woodpecker Medical Instrument Co., Ltd. · 2021 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934949 | Digora | Orion Corporation Soredex | 1994 | — |
| 0 (this device) | K041050 | Digora Optime (or Digora Ontime) | Soredex Palodex Group OY | 2004 | — |
| +1 | K133231 | Digora Optime | Instrumentarium Dental, Palodex Group OY | 2014 | — |
| +1 | K131442 | Firecr Dentalimaging System | 3Disc Americas | 2013 | — |
| +2 | K160788 | RIOScan (RPS500) | Ray Co., Ltd. | 2016 | — |
| +3 | K170733 | ScanX Intraoral View | Duerr Dental AG | 2017 | — |
| +4 | K212080 | Imaging Plate Scanner, i-Scan | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 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 |
|---|---|---|---|
| * | K934949 | DigoraSummary page 1…Common Name Imaging plate reader Classification Solid state x-ray imager Predicate Device Digora 510(k): K934949 Product Description A digital radiography system for intra oral imaging plates located indisposable bags.… | 1994 |
What descends from it? (14)
See all 144 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 7, 2020 | Class II | Z-0842-2020 | Component design/selection | Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually… |
| Jan 7, 2020 | Class II | Z-0839-2020 | Component design/selection | Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually… |
| Jan 7, 2020 | Class II | Z-0841-2020 | Component design/selection | Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually… |
| Jan 7, 2020 | Class II | Z-0840-2020 | Component design/selection | Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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.
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/K041050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041050: Digora Optime (or Digora Ontime).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041050
Report an extraction error
Are you the manufacturer?
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