510(k) · Cleared
ClearedRIS500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ray Co., Ltd. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jan 23, 2015 as substantially equivalent to K121132 (Humanray Co,Ltd, 2012) and 1 other predicate after a 98-day review. Its family tree reaches back 6 generations to 1994. 2 later devices descend from it.
- Decided
- Jan 23, 2015
- Review
- 98 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K933455 (1994). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- 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 backK090526 Medical Image Processing Unit, Model EzsensorE-Woo Technology · 2009
- 2 generations backK113360 Medical Image Processing UnitHumanray Co,Ltd · 2012
- 1 generation backK121132 Ezsensor P Digital Intraoral SensorHumanray Co,Ltd · 2012
- This deviceK143000 RIS500Ray Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK201247 Intraoral SensorDentium Co., Ltd (Ict Branch) · 2020
- Descendant · cites it directly · 0 of its ownK153710 Tuxedo Digital Dental SensorLed Dental, Inc. · 2016
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 |
|---|---|---|---|---|---|
| −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 | K090526 | Medical Image Processing Unit, Model Ezsensor | E-Woo Technology | 2009 | — |
| −2 | K113360 | Medical Image Processing Unit | Humanray Co,Ltd | 2012 | — |
| −1 | K121132 | Ezsensor P Digital Intraoral Sensor | Humanray Co,Ltd | 2012 | — |
| 0 (this device) | K143000 | RIS500 | Ray Co., Ltd. | 2015 | — |
| +1 | K201247 | Intraoral Sensor | Dentium Co., Ltd (Ict Branch) | 2020 | — |
| +1 | K153710 | Tuxedo Digital Dental Sensor | Led Dental, Inc. | 2016 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K121132 | Ezsensor P Digital Intraoral SensorSummary page 6…rofessionals. Predicate device 1) Predicate device-1 Manufacturer: HUMANRAY Co., Ltd. Device: EzSensor T 510(k) Number: K121132 2) Predicate device-2 Manufacturer: E-WOO TECHNOLOGY Device: EzSensor 510(k) Number: K09052… | 2012 |
| * | K090526 | Medical Image Processing Unit, Model EzsensorSummary page 6…e: EzSensor T 510(k) Number: K121132 2) Predicate device-2 Manufacturer: E-WOO TECHNOLOGY Device: EzSensor 510(k) Number: K090526 Statement of Substantial Equivalence Parameter Proposed Device Predicated Device… | 2009 |
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 21 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K201247 (Dentium Co., Ltd (Ict Branch), 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K121132.
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. 2015, 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?
This system 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/K143000 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143000: RIS500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143000
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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