510(k) · Cleared
ClearedProgeny Imaging Software, Model# 500-405 (6,7,8).
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Progeny, Inc. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Apr 26, 2007 as substantially equivalent to K060178 (Gendex Dental Systems, 2006) and 1 other predicate after a 48-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Apr 26, 2007
- Review
- 48 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K930527 (1993). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK930527 Dental LinkEscan, Inc. · 1993
- 4 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 3 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 2 generations backK050744 Kavo Ergocom/ErgocamKavo America Corporation · 2005
- 1 generation backK060178 Vix Win ProGendex Dental Systems · 2006 · Recalled
- This deviceK070664 Progeny Imaging Software, Model# 500-405 (6,7,8).Progeny, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −4 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −3 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −2 | K050744 | Kavo Ergocom/Ergocam | Kavo America Corporation | 2005 | — |
| −1 | K060178 | Vix Win Pro | Gendex Dental Systems | 2006 | 1 |
| 0 (this device) | K070664 | Progeny Imaging Software, Model# 500-405 (6,7,8). | Progeny, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2002 | 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? (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 |
|---|---|---|---|
| * | K060178 | Vix Win ProSummary page 2…al major independent manufacturers of Intra Oral diagnostic Radiographic software display systems on the U.S. market. One is the Gendex Vix Win Pro. The 510(k) number is K060178. The classification of the Dentsply device is listed as product code 90 MUH. Another currently marketed device is the Schick CDR… | 2006 |
| * | K022953 | Modification to Computed Oral Radiology SystemSummary page 2…of the Dentsply device is listed as product code 90 MUH. Another currently marketed device is the Schick CDR software, manufactured by Schick, Inc. The 510(k) number is K022953. The classification of the Schick CDR is listed as product code 90 MUH. Comparison Table: Characteristic Vix Win Pro… | 2002 |
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 14 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 5 other devices also cite its predicate K060178.
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. 2007, 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 intended use of the Progeny Imaging software is to act as a diagnostic imaging display of digitally acquired dental x-ray images. The software can also display images from intra oral video cameras.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070664 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070664: Progeny Imaging Software, Model# 500-405 (6,7,8)..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070664
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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