510(k) · Cleared
ClearedProgeny Mpse Intraoral Dental X-Ray Sensor
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 Aug 9, 2004 as substantially equivalent to K933455 (Schick Technologies, Inc., 1994) and 1 other predicate after a 33-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Aug 9, 2004
- Review
- 33 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K933455 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- This deviceK041831 Progeny Mpse Intraoral Dental X-Ray SensorProgeny, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| 0 (this device) | K041831 | Progeny Mpse Intraoral Dental X-Ray Sensor | Progeny, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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? (4)
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 |
|---|---|---|---|
| * | K933455 | Computed Oral Radiology SystemSummary page 2…lassification of the Trophy Radiologie device is listed as product code EAP. The other currently marketed device is the Schick Technologies CDR. The 510(k) number is K933455. The classification of the Schick Technologies CDR is listed as product code EAP. Labeling for the currently marketed devices… | 1994 |
| * | K950533 | Trophy Radiologie RVG RadiovisiographySummary page 2…here are several major independent manufacturers of Intraoral Diagnostic Radiographic Systems on the US market. One is the Trophy Radiologie RVG. The 5 10(k) number is K950533. The classification of the Trophy Radiologie device is listed as product code EAP. The other currently marketed device is the… | 1995 |
| * | — | VisioDent RSV Named without a submission number | |
| * | — | Durr Dental Vista Ray Named without a submission number |
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?
- None of the 2 ancestors has a recall.
- 9 other devices also cite its predicate K933455.
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 Progeny MPSe system is intended to use for acquisition of digital images of intra-oral tissue including teeth on a COD X-ray sensor, and transmit images to a computer for display by Ethernet.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041831: Progeny Mpse Intraoral Dental X-Ray Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041831
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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