510(k) · Cleared
ClearedEagle S/Saevo Slim/D700 Slim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliage S/A Industrias Medica Odontológico. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Apr 11, 2023 as substantially equivalent to K162585 (Suni Medical Imaging, Inc., 2016) after a 26-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Apr 11, 2023
- Review
- 26 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K021718 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK021718 Intraoral Imaging System, Model Suni-RaySuni Imaging Microsystems, Inc. · 2002
- 2 generations backK070219 Suniray II Digital Radiography SystemSuni Medical Imaging, Inc. · 2007
- 1 generation backK162585 SuniIQ Digital Radiography SystemSuni Medical Imaging, Inc. · 2016
- This deviceK230732 Eagle S/Saevo Slim/D700 SlimAlliage S/A Industrias Medica Odontológico. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K021718 | Intraoral Imaging System, Model Suni-Ray | Suni Imaging Microsystems, Inc. | 2002 | — |
| −2 | K070219 | Suniray II Digital Radiography System | Suni Medical Imaging, Inc. | 2007 | — |
| −1 | K162585 | SuniIQ Digital Radiography System | Suni Medical Imaging, Inc. | 2016 | — |
| 0 (this device) | K230732 | Eagle S/Saevo Slim/D700 Slim | Alliage S/A Industrias Medica Odontológico. | 2023 | — |
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 |
|---|---|---|---|
| * | K162585 | SuniIQ Digital Radiography SystemSummary page 4…de: MUH Secondary Product Codes: EHD, MQB Regulation Number: 872.1800 Device Class: 2 3. Legally Marketed Predicate Device Information: 510(k) Number: K162585 Manufacturer: Suni Medical Imaging, Inc Trade /Proprietary Name: SuniIQ Digital Radiography System Device: Dent… | 2016 |
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 21 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- None of the 3 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. 2023, 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 Intraoral Dental Digital Imaging Sensor is aimed at the acquisition of intra-oral medical images from
teeth, jaw and oral structure, only for exclusive dental use and must be handled by trained and qualified
health professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230732 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230732: Eagle S/Saevo Slim/D700 Slim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230732
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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