510(k) · Cleared
ClearedMedical Image Processing Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Humanray Co,Ltd · EAP Unit, X-Ray, Intraoral
Cleared on Feb 7, 2012 as substantially equivalent to K090526 (E-Woo Technology, 2009) after an 85-day review. Its family tree reaches back 4 generations to 1994. 5 later devices descend from it.
- Decided
- Feb 7, 2012
- Review
- 85 days
- Class
- Class II
- Product code
- EAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K933455 (1994). 5 ancestors in all. 5 later devices descend from it, 1 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 backK090526 Medical Image Processing Unit, Model EzsensorE-Woo Technology · 2009
- This deviceK113360 Medical Image Processing UnitHumanray Co,Ltd · 2012
- Descendant · cites it directly · 4 of its ownK121132 Ezsensor P Digital Intraoral SensorHumanray Co,Ltd · 2012
- Descendant · 2 generations on · 2 of its ownK143000 RIS500Ray Co., Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK201247 Intraoral SensorDentium Co., Ltd (Ict Branch) · 2020
- Descendant · 3 generations on · 0 of its ownK153710 Tuxedo Digital Dental SensorLed Dental, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK140060 Digital Dental Intra Oral Sensor, Hdi 2000, Hdi 2000ARayence Co., Ltd. · 2014
Most influential descendants
Showing 5 of 5 · See all- K121132Ezsensor P Digital Intraoral SensorHumanray Co,Ltd · 2012 · cites it directly4descendants
- K143000RIS500Ray Co., Ltd. · 2015 · 2 generations on2descendants
- K201247Intraoral SensorDentium Co., Ltd (Ict Branch) · 2020 · 3 generations on0descendants
- K153710Tuxedo Digital Dental SensorLed Dental, Inc. · 2016 · 3 generations on0descendants
- K140060Digital Dental Intra Oral Sensor, Hdi 2000, Hdi 2000ARayence Co., Ltd. · 2014 · 2 generations on0descendants
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 | K090526 | Medical Image Processing Unit, Model Ezsensor | E-Woo Technology | 2009 | — |
| 0 (this device) | K113360 | Medical Image Processing Unit | Humanray Co,Ltd | 2012 | — |
| +1 | K121132 | Ezsensor P Digital Intraoral Sensor | Humanray Co,Ltd | 2012 | — |
| +2 | K143000 | RIS500 | Ray Co., Ltd. | 2015 | — |
| +3 | K201247 | Intraoral Sensor | Dentium Co., Ltd (Ict Branch) | 2020 | — |
| +3 | K153710 | Tuxedo Digital Dental Sensor | Led Dental, Inc. | 2016 | — |
| +2 | K140060 | Digital Dental Intra Oral Sensor, Hdi 2000, Hdi 2000A | Rayence Co., Ltd. | 2014 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 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 EAP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K090526 | Medical Image Processing Unit, Model EzsensorSummary page 2…ewed, and manipulated for diagnostic use by dentists. Predicate Device: Manufacturer : HUMANRAY Co., Ltd. Device : EzSensor 510(k) Number Substantial Equivalence: : K090526 (Decision Date — DEC/02/2009) EzSensor T described in this 510(k) has the same intended use and similar technical characteristic… | 2009 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121132 | Ezsensor P Digital Intraoral Sensor | 2012 | 4 |
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 18 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K121132 (Humanray Co,Ltd, 2012) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K090526.
How does its category compare?
All EAP devicesEAP Unit, X-Ray, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · EAP
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · EAP
Too few EAP 510(k)s in any year since 2007 to give a median.
Recalls per year · EAP
3in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EAP
1in 2025
MAUDE reports naming product code EAP, 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 | 0 | — | 0 | 6 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 3 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
EzSensor T, Intra-oral Imaging System, is 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.
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/K113360 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113360: Medical Image Processing Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113360
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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