510(k) · Cleared
ClearedSuniray II Digital Radiography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suni Medical Imaging, Inc. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Feb 7, 2007 as substantially equivalent to K021718 (Suni Imaging Microsystems, Inc., 2002) after a 15-day review. Its family tree reaches back 1 generation to 2002. 35 later devices descend from it.
- Decided
- Feb 7, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021718 (2002). 35 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK021718 Intraoral Imaging System, Model Suni-RaySuni Imaging Microsystems, Inc. · 2002
- This deviceK070219 Suniray II Digital Radiography SystemSuni Medical Imaging, Inc. · 2007
- Descendant · cites it directly · 18 of its ownK090458 Dexis SensorDexis, LLC · 2009
- Descendant · cites it directly · 13 of its ownK103290 Edlen Imaging - Gemini DusbEdlen Imaging, LLC · 2011
- Descendant · 2 generations on · 11 of its ownK150823 EDLENi Intra-Oral SensorEdlen Imaging, LLC · 2015
- Descendant · 3 generations on · 10 of its ownK151926 QuickRay HD Intraoral SensorDenterprise International, Inc. · 2015
- Descendant · 2 generations on · 5 of its ownK210312 PlutoX Digital Intraoral X-Ray Imaging SystemIray Technology Taicang, Ltd. · 2021
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K090458Dexis SensorDexis, LLC · 2009 · cites it directly18descendants
- K103290Edlen Imaging - Gemini DusbEdlen Imaging, LLC · 2011 · cites it directly13descendants
- K150823EDLENi Intra-Oral SensorEdlen Imaging, LLC · 2015 · 2 generations on11descendants
- K151926QuickRay HD Intraoral SensorDenterprise International, Inc. · 2015 · 3 generations on10descendants
- K210312PlutoX Digital Intraoral X-Ray Imaging SystemIray Technology Taicang, Ltd. · 2021 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021718 | Intraoral Imaging System, Model Suni-Ray | Suni Imaging Microsystems, Inc. | 2002 | — |
| 0 (this device) | K070219 | Suniray II Digital Radiography System | Suni Medical Imaging, Inc. | 2007 | — |
| +1 | K090458 | Dexis Sensor | Dexis, LLC | 2009 | — |
| +1 | K103290 | Edlen Imaging - Gemini Dusb | Edlen Imaging, LLC | 2011 | — |
| +2 | K150823 | EDLENi Intra-Oral Sensor | Edlen Imaging, LLC | 2015 | — |
| +3 | K151926 | QuickRay HD Intraoral Sensor | Denterprise International, Inc. | 2015 | — |
| +2 | K210312 | PlutoX Digital Intraoral X-Ray Imaging System | Iray Technology Taicang, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 7 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K021718 | Intraoral Imaging System, Model Suni-RaySummary page 1…Suni Medical Imaging, Inc. 6840 Via Del Oro San Jose, CA 95119 Reason for Pre-Market Notification New design Equivalent Legally Marketed Device K021718 Suni Intraoral Imaging System Indications for Use: The SuniRay II Digital Radiography System is used to coll… | 2002 |
What descends from it? (35)
See all 353 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 SuniRay II Digital Radiography System is used to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070219: Suniray II Digital Radiography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070219
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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