510(k) · Cleared
ClearedClio Prime and Clio Pedo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sota Precision Optics, Inc. Dba Sota Imaging · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Nov 6, 2020 as substantially equivalent to K090458 (Dexis, LLC, 2009) after a 53-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it.
- Decided
- Nov 6, 2020
- Review
- 53 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K933455 (1994). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- 3 generations backK022953 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2002
- 2 generations backK072134 Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
- 1 generation backK090458 Dexis SensorDexis, LLC · 2009
- This deviceK202664 Clio Prime and Clio PedoSota Precision Optics, Inc. Dba Sota Imaging · 2020
- Descendant · cites it directly · 1 of its ownK221955 Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20Realcloud Imaging Inc. Dba Realcloud Imaging · 2022
- Descendant · 2 generations on · 0 of its ownK241649 DUO1 and DUO2Zinnovi, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −3 | K022953 | Modification to Computed Oral Radiology System | Schick Technologies, Inc. | 2002 | — |
| −2 | K072134 | Schick Computed Oral Radiology System | Schick Technologies, Inc. | 2007 | — |
| −1 | K090458 | Dexis Sensor | Dexis, LLC | 2009 | — |
| 0 (this device) | 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 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 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 |
|---|---|---|---|
| * | K090458 | Dexis SensorSummary page 5…of Predicate Device Owner/Operator/Manufacturer: Dental Imaging Technologies Corporation Establishment Registration Number: 2530069 510(k) Premarket Notification Number: K090458 Contract Manufacturer: BAE Systems Imaging Solutions, a division of BAE Systems Inc. Trade Name: DEXIS Platinum sensor and GENDEX… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221955 | Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 | 2022 | 1 |
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 26 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K221955 (Realcloud Imaging Inc. Dba Realcloud Imaging, 2022) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K090458.
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. 2020, 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?
Clio Prime and Clio Pedo are USB-driven, digital intraoral x-ray sensors which are intended to acquire dental intraoral radiography images. Clio Prime or Clio Pedo shall be operated by healthcare professionals who are educated and competent to perform the acquisition of dental intraoral radiographs. Clio Prime or Clio Pedo can be used either in combination with special positioning devices to facilitate positioning and alignment with an x-ray beam, or Clio Prime or Clio Pedo can also be positioned by hand with the assistance of the patient.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202664: Clio Prime and Clio Pedo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202664
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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