510(k) · Cleared
ClearedIntraoral Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentium Co., Ltd (Ict Branch) · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jun 10, 2020 as substantially equivalent to K143000 (Ray Co., Ltd., 2015) after a 30-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Jun 10, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K933455 (1994). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- 6 generations backK022953 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2002
- 5 generations backK072134 Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
- 4 generations backK090526 Medical Image Processing Unit, Model EzsensorE-Woo Technology · 2009
- 3 generations backK113360 Medical Image Processing UnitHumanray Co,Ltd · 2012
- 2 generations backK121132 Ezsensor P Digital Intraoral SensorHumanray Co,Ltd · 2012
- 1 generation backK143000 RIS500Ray Co., Ltd. · 2015
- This deviceK201247 Intraoral SensorDentium Co., Ltd (Ict Branch) · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −6 | K022953 | Modification to Computed Oral Radiology System | Schick Technologies, Inc. | 2002 | — |
| −5 | K072134 | Schick Computed Oral Radiology System | Schick Technologies, Inc. | 2007 | — |
| −4 | K090526 | Medical Image Processing Unit, Model Ezsensor | E-Woo Technology | 2009 | — |
| −3 | K113360 | Medical Image Processing Unit | Humanray Co,Ltd | 2012 | — |
| −2 | K121132 | Ezsensor P Digital Intraoral Sensor | Humanray Co,Ltd | 2012 | — |
| −1 | K143000 | RIS500 | Ray Co., Ltd. | 2015 | — |
| 0 (this device) | K201247 | Intraoral Sensor | Dentium Co., Ltd (Ict Branch) | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 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 |
|---|---|---|---|
| * | K143000 | RIS500Summary page 4…R 892.1680 Regulatory Class: II Product code: MQB, MUH Panel: Radiology Predicate device Predicate device (K143000) Trade/Device Name: RIO Sensor (RIS 500) Regulation Number: 21 CFR 892.1680 Regulation Name:… | 2015 |
| † | K090526 | Medical Image Processing Unit, Model Ezsensor | 2009 |
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 26 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K143000.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
Intra Oral Sensor (model: IOX 1 / IOX 2) is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, views and manipulated for diagnostic use by dentists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201247 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201247: Intraoral Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201247
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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