510(k) · Cleared
ClearedDigora for Windows 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orion Corporation Soredex · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Dec 30, 1998 as substantially equivalent to K962699 (Applicare Medical Imaging, B.V., 1996) after a 104-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Dec 30, 1998
- Review
- 104 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K896095 (1990). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 1 generation backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- This deviceK983267 Digora for Windows 2.0Orion Corporation Soredex · 1998
- Descendant · cites it directly · 0 of its ownK211317 CruxviewCruxell Corp. · 2021
Most influential descendants
Showing 1 of 1 · See all- K211317CruxviewCruxell Corp. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −1 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| 0 (this device) | K983267 | Digora for Windows 2.0 | Orion Corporation Soredex | 1998 | — |
| +1 | K211317 | Cruxview | Cruxell Corp. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K962699 | Radworks Medical Imaging SoftwareSummary page 1…Name: System, Digital image communications 111 Substantial Equivalent Devices Digora for Windows 2.0 is substantially equivalent to Radworks Medical Imaging Software (K962699) IV Product Description Digora for Windows 2.0 is a dental imaging, image processing and archiving software, mainly to be used… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211317 | Cruxview | 2021 | 0 |
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 8 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K211317 (Cruxell Corp., 2021) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K962699.
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 for Windows 2.0 is a software device iqtended to using and managing dental x-ray images sent by Digora imaging plate scanner, storing the images and allowing the user to process and examine the images in order to achieve improved diagnoseg. The sqftware can also support other imaging devices such as larger size imaging plate scanners and intraoral video cameras.
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/K983267 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983267: Digora for Windows 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/K983267
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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