510(k) · Cleared
ClearedX-VIEW
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sometech Corporation · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Apr 1, 2004 as substantially equivalent to K962337 (Trophy Radiologie, 1996) and 1 other predicate after a 469-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Apr 1, 2004
- Review
- 469 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923067 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK923067 Sens-a-RayRegam Medical Systems · 1992
- This deviceK024186 X-VIEWSometech Corporation · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923067 | Sens-a-Ray | Regam Medical Systems | 1992 | — |
| 0 (this device) | K024186 | X-VIEW | Sometech Corporation | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 |
|---|---|---|---|
| * | K962337 | Elitys or Elitys-ESummary page 2…the use of conventional x-ray films. The sensor, upon radiation exposure, Captures the images into a computer for viewing, storage, and printing Just like Trophy's RVG (K962337) and Regam's Sens-A-Ray (K923067) X-View is similar in its intended use. The X-View System, along with the aforementioned other s… | 1996 |
| * | K923067 | Sens-a-RaySummary page 2…ms. The sensor, upon radiation exposure, Captures the images into a computer for viewing, storage, and printing Just like Trophy's RVG (K962337) and Regam's Sens-A-Ray (K923067) X-View is similar in its intended use. The X-View System, along with the aforementioned other systems, consists of a sensor and… | 1992 |
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.
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 X - VIEW System is a device used to provide instant images of the human oral tissue and teeth without the use of conventional x-ray films. While an X-Ray machine is still utilized, the acquisition of an image requires up to 90% less radiation than a conventional system would require to produce the same image.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024186 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024186: X-VIEW.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024186
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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