510(k) · Cleared
ClearedDigital Intraoral X-ray Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Xpectvision Technology Co., Ltd. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Feb 17, 2022 as substantially equivalent to K072134 (Schick Technologies, Inc., 2007) after a 17-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Feb 17, 2022
- Review
- 17 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K933455 (1994). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- 2 generations backK022953 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2002
- 1 generation backK072134 Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
- This deviceK220277 Digital Intraoral X-ray SensorShenzhen Xpectvision Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK251793 SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp. · 2026
- Descendant · cites it directly · 0 of its ownK230916 WeSensorPicopack, Inc. · 2023
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 |
|---|---|---|---|---|---|
| −3 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −2 | K022953 | Modification to Computed Oral Radiology System | Schick Technologies, Inc. | 2002 | — |
| −1 | K072134 | Schick Computed Oral Radiology System | Schick Technologies, Inc. | 2007 | — |
| 0 (this device) | K220277 | Digital Intraoral X-ray Sensor | Shenzhen Xpectvision Technology Co., Ltd. | 2022 | — |
| +1 | K251793 | SOTA Cloud Smart Sensor (1.5) | Sota Cloud Corp. | 2026 | — |
| +1 | K230916 | WeSensor | Picopack, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K072134 | Schick Computed Oral Radiology SystemSummary page 6…ber: 21 CFR 872.1800 Product Code: MUH Classification Name: Extraoral source x-ray system FDA 510 (k) #: K072134 Device Class: Class II 5. Indications for Use The digital intraoral X-ray sensors XVD2121 Plus, XVD2530… | 2007 |
What descends from it? (2)
2 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 28 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K251793 (Sota Cloud Corp., 2026) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K072134.
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. 2022, 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 intraoral X-ray sensors XVD2121 Plus, XVD2530 are intended for any dental practice that uses X-ray equipment for intraoral diagnostic purposes. Each can be used by trained dental professionals for patients receiving intraoral X-ray examinations and produces digital images that can be displayed and archived digitally.
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/K220277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220277: Digital Intraoral X-ray Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220277
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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