510(k) · Cleared
ClearedI-Max Touch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Owandy · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Jun 2, 2009 as substantially equivalent to K002432 (Villa Sistemi Medicali S.P.A., 2000) and 1 other predicate after a 231-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Jun 2, 2009
- Review
- 231 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K961826 (1996). 7 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961826 | Digipan | Trophy Radiologie | 1996 | — |
| −2 | K983283 | Signet Dxis Direct X-Ray Imaging System | Signet Radiology, Inc. | 1998 | — |
| −1 | K041120 | EV Apan Digital, Model K1VSM2000 | Afp Imaging Corp. | 2004 | — |
| 0 (this device) | K083057 | I-Max Touch | Owandy | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K002432 | Strato XSummary page 1…d as substantially equivalent to the STRATO 2000 D, manufactured by VILLA SISTEMI MEDICALI (X-ray system) and OWANDY (digital acquisition device) and cleared by FDA with K002432 (VILLA) and K041120 (OWANDY). See comparison table in Chapter 3. The following table comp ares the two units:… | 2000 |
| * | K041120 | EV Apan Digital, Model K1VSM2000Summary page 1…quivalent to the STRATO 2000 D, manufactured by VILLA SISTEMI MEDICALI (X-ray system) and OWANDY (digital acquisition device) and cleared by FDA with K002432 (VILLA) and K041120 (OWANDY). See comparison table in Chapter 3. The following table comp ares the two units: Trade Name… | 2004 |
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 13 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K002432.
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. 2009, 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 I-Max Touch (PAN and Ceph) is a digital image acquisition system to be used in conjunction with a Villa Sistemi Medicali Digital Panoramic X-ray System, such as I-Max Plus or Strato D, to capture images by a sensor, digitalize the image, review images and format images to be sent to a PC, according to a standard protocol, through the existing acquisition board of panoramic system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083057 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083057: I-Max Touch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083057
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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