510(k) · Cleared
ClearedTuxDeluxe (Size 1 6100B, Size 2 6101B)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tuxedo Imaging, LLC · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Oct 20, 2023 as substantially equivalent to K220422 (Iray Technology Taicang, Ltd., 2022) after a 58-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Oct 20, 2023
- Review
- 58 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 backK210312 PlutoX Digital Intraoral X-Ray Imaging SystemIray Technology Taicang, Ltd. · 2021
- 1 generation backK220422 Dental sensors NanoPix1, NanoPix2Iray Technology Taicang, Ltd. · 2022
- This deviceK232552 TuxDeluxe (Size 1 6100B, Size 2 6101B)Tuxedo Imaging, LLC · 2023
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 | K210312 | PlutoX Digital Intraoral X-Ray Imaging System | Iray Technology Taicang, Ltd. | 2021 | — |
| −1 | K220422 | Dental sensors NanoPix1, NanoPix2 | Iray Technology Taicang, Ltd. | 2022 | — |
| 0 (this device) | K232552 | TuxDeluxe (Size 1 6100B, Size 2 6101B) | Tuxedo Imaging, LLC | 2023 | — |
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 |
|---|---|---|---|
| * | K220422 | Dental sensors NanoPix1, NanoPix2Summary page 4…Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH 3. Legally Marketed Predicate Device Information: K220422 Manufacturer: iRay Technology Taicang Ltd. Trade/Device Name: Dental Sensors NanoPix1, NanoPix2 Regulatio… | 2022 |
| † | K160232 | Disposable Barrier Sleeves and Covers | 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 29 years and passes through 4 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. 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?
Dental Sensors, models Tuxdeluxe, 6100B-Size 1, and 6101B-Size 2 are intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists. This device must only be used in hospital environments, clinics or dental offices by trained and qualified dental personnel, and not used in the oxygen rich environment. This device is suitable for providing dental radiography imaging for both adult and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232552: TuxDeluxe (Size 1 6100B, Size 2 6101B).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232552
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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