510(k) · Cleared
ClearedDUO1 and DUO2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zinnovi, Inc. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Jul 5, 2024 as substantially equivalent to K221955 (Realcloud Imaging Inc. Dba Realcloud Imaging, 2022) after a 28-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Jul 5, 2024
- Review
- 28 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K933455 (1994). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- 5 generations backK022953 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2002
- 4 generations backK072134 Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
- 3 generations backK090458 Dexis SensorDexis, LLC · 2009
- 2 generations backK202664 Clio Prime and Clio PedoSota Precision Optics, Inc. Dba Sota Imaging · 2020
- 1 generation backK221955 Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20Realcloud Imaging Inc. Dba Realcloud Imaging · 2022
- This deviceK241649 DUO1 and DUO2Zinnovi, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −5 | K022953 | Modification to Computed Oral Radiology System | Schick Technologies, Inc. | 2002 | — |
| −4 | K072134 | Schick Computed Oral Radiology System | Schick Technologies, Inc. | 2007 | — |
| −3 | K090458 | Dexis Sensor | Dexis, LLC | 2009 | — |
| −2 | K202664 | Clio Prime and Clio Pedo | Sota Precision Optics, Inc. Dba Sota Imaging | 2020 | — |
| −1 | K221955 | Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 | Realcloud Imaging Inc. Dba Realcloud Imaging | 2022 | — |
| 0 (this device) | K241649 | DUO1 and DUO2 | Zinnovi, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K221955 | Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20Summary page 4…Identification of Predicate Device Owner/Operator: RealCloud Imaging Inc. doing business as RealCloud Imaging 510(k) Premarket Notification Number: K221955 Trade Name: Brasseler GEM… | 2022 |
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 30 years and passes through 5 companies; a new generation was cleared every 5.1 years on median.
- None of the 9 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. 2024, 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 DUO Sensors are USB driven intraoral sensors which are intended to acquire intraoral radiographic images. The DUO Sensors shall be operated by trained healthcare professionals, who are educated and competent to perform the acquisition of intraoral radiographs.
The DUO Sensors can be used either in combination with special positioning devices to facilitate positioning and alignment with the X-ray beam or they may also be positioned by hand with the assistance of the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241649: DUO1 and DUO2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241649
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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