510(k) · Cleared
ClearedPlutoX Digital Intraoral X-Ray Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iray Technology Taicang, Ltd. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Apr 23, 2021 as substantially equivalent to K090458 (Dexis, LLC, 2009) after a 79-day review. Its family tree reaches back 4 generations to 1994. 5 later devices descend from it.
- Decided
- Apr 23, 2021
- Review
- 79 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. 5 later devices descend from it, 4 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 deviceK210312 PlutoX Digital Intraoral X-Ray Imaging SystemIray Technology Taicang, Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK220422 Dental sensors NanoPix1, NanoPix2Iray Technology Taicang, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK230998 Digital Wireless Intraoral X-Ray SensorIray Imaging Technology (Haining) Limited · 2023
- Descendant · 2 generations on · 0 of its ownK232552 TuxDeluxe (Size 1 6100B, Size 2 6101B)Tuxedo Imaging, LLC · 2023
- Descendant · cites it directly · 0 of its ownK230811 Digital Intraoral X-Ray SensorIray Imaging Technology (Haining) Limited · 2023
- Descendant · cites it directly · 0 of its ownK212279 Digital Intraoral X-ray Imaging SystemIray Technology Taicang, Ltd. · 2021
Most influential descendants
Showing 5 of 5 · See all- K220422Dental sensors NanoPix1, NanoPix2Iray Technology Taicang, Ltd. · 2022 · cites it directly1descendant
- K230998Digital Wireless Intraoral X-Ray SensorIray Imaging Technology (Haining) Limited · 2023 · cites it directly0descendants
- K232552TuxDeluxe (Size 1 6100B, Size 2 6101B)Tuxedo Imaging, LLC · 2023 · 2 generations on0descendants
- K230811Digital Intraoral X-Ray SensorIray Imaging Technology (Haining) Limited · 2023 · cites it directly0descendants
- K212279Digital Intraoral X-ray Imaging SystemIray Technology Taicang, Ltd. · 2021 · cites it directly0descendants
View 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) | K210312 | PlutoX Digital Intraoral X-Ray Imaging System | Iray Technology Taicang, Ltd. | 2021 | — |
| +1 | K220422 | Dental sensors NanoPix1, NanoPix2 | Iray Technology Taicang, Ltd. | 2022 | — |
| +1 | K230998 | Digital Wireless Intraoral X-Ray Sensor | Iray Imaging Technology (Haining) Limited | 2023 | — |
| +2 | K232552 | TuxDeluxe (Size 1 6100B, Size 2 6101B) | Tuxedo Imaging, LLC | 2023 | — |
| +1 | K230811 | Digital Intraoral X-Ray Sensor | Iray Imaging Technology (Haining) Limited | 2023 | — |
| +1 | K212279 | Digital Intraoral X-ray Imaging System | Iray Technology Taicang, Ltd. | 2021 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 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 6…pplication Model Name: GXS-700 Product Code: MUH Classification Name: Extraoral Source X-ray System FDA 510 (k) #: K090458 Device Class: Class II 5. Description of the Device [21 CFR 807.92(a)(4)1 The PlutoX Digital Intraoral X-Ray I… | 2009 |
What descends from it? (5)
4 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?
- The line of descent spans 27 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, K220422 (Iray Technology Taicang, Ltd., 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. 2021, 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 Digital Intra-Oral X-Ray Imaging System (PlutoOOOX/PlutoOO02X) is used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors.
This device is not intended for mammography and conventional photography applications.
This device is suitable for providing dental radiography imaging for both adult and pediatric.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210312: PlutoX Digital Intraoral X-Ray Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210312
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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