510(k) · Cleared
ClearedPAPAYA 3D Premium & PAPAYA 3D Premium Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genoray Co., Ltd. · OAS X-Ray, Tomography, Computed, Dental
Cleared on Sep 16, 2020 as substantially equivalent to K150354 (Genoray Co., Ltd., 2015) after a 203-day review. Its family tree reaches back 10 generations to 1997. 1 later device descends from it.
- Decided
- Sep 16, 2020
- Review
- 203 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K973642 (1997). 15 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 6 generations between
- 3 generations backK130419 Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2013
- 2 generations backK141700 Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2014
- 1 generation backK150354 PAPAYA 3D PlusGenoray Co., Ltd. · 2015
- This deviceK200469 PAPAYA 3D Premium & PAPAYA 3D Premium PlusGenoray Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK250060 GT300; GT300-CGenoray Co., Ltd. · 2025
Show all 10 generations
- Root · 10 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 9 generations backK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- 8 generations backK082350 PAX-500VATECH Co., Ltd. · 2008
- 7 generations backK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- 6 generations backK102259 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2011
- 5 generations backK113672 PCH-2500 Digital Extraoral Source X-Ray SystemVATECH Co., Ltd. · 2012
- 4 generations backK122155 PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital…VATECH Co., Ltd. · 2012
- 3 generations backK130419 Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2013
- 2 generations backK141700 Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2014
- 1 generation backK150354 PAPAYA 3D PlusGenoray Co., Ltd. · 2015
- This deviceK200469 PAPAYA 3D Premium & PAPAYA 3D Premium PlusGenoray Co., Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K250060GT300; GT300-CGenoray Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −9 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| −8 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| −7 | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| −6 | K102259 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2011 | — |
| −5 | K113672 | PCH-2500 Digital Extraoral Source X-Ray System | VATECH Co., Ltd. | 2012 | — |
| −4 | K122155 | PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital Extraoral Source… | VATECH Co., Ltd. | 2012 | — |
| −3 | K130419 | Papaya Plus, Digital Extraoral Source X-Ray System | Genoray Co., Ltd. | 2013 | — |
| −2 | K141700 | Papaya Plus, Digital Extraoral Source X-Ray System | Genoray Co., Ltd. | 2014 | — |
| −1 | K150354 | PAPAYA 3D Plus | Genoray Co., Ltd. | 2015 | — |
| 0 (this device) | K200469 | PAPAYA 3D Premium & PAPAYA 3D Premium Plus | Genoray Co., Ltd. | 2020 | — |
| +1 | K250060 | GT300; GT300-C | Genoray Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 OAS? 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 OAS device
- #1 K213226 RCT700score 18.0 · 13 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 |
|---|---|---|---|
| * | K150354 | PAPAYA 3D PlusSummary page 4…umber: 21 CFR 892.1750 B Device Class: Class IT B Primary Product code: OAS B Secondary product code: MUH 4. Predicate Device ivalent Marketed Device PAPAYA 3D Plus (K150354, GENORAY Co., Ltd) 5. Description of the Device The proposed device PAPAYA 3D Premium & PAPAYA 3D Premium Plus the computed tom… | 2015 |
| † | K182805 | RCT800 | 2018 |
| † | K103182 | Triana, Picture Archiving and Communications System | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250060 | GT300; GT300-C | 2025 | 0 |
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 23 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K250060 (Genoray Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K150354.
How does its category compare?
All OAS devicesOAS X-Ray, Tomography, Computed, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OAS
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAS
144in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAS
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAS
1in 2025
MAUDE reports naming product code OAS, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 6 | 168 | 0 | 0 |
| 2012 | 7 | 110 | 0 | 0 |
| 2013 | 10 | 155 | 0 | 0 |
| 2014 | 5 | 170 | 0 | 0 |
| 2015 | 5 | 164 | 1 | 0 |
| 2016 | 12 | 154 | 0 | 0 |
| 2017 | 4 | 209 | 0 | 0 |
| 2018 | 11 | 57 | 0 | 0 |
| 2019 | 7 | 55 | 0 | 1 |
| 2020 | 9 | 113 | 0 | 0 |
| 2021 | 11 | 92 | 0 | 0 |
| 2022 | 6 | 105 | 0 | 1 |
| 2023 | 12 | 77 | 0 | 1 |
| 2024 | 4 | 129 | 0 | 2 |
| 2025 | 9 | 144 | 3 | 1 |
| 2026 | 9 | 77 | 0 | — |
What is it indicated for?
The X-ray unit system is a diagnostic imaging system which consists of multiple image acquisition modes; panoramic, cephalometric, and CBCT (Cone Beam Computed Tomography). X-ray unit system is used for dental radiographic examination and diagnosis of teeth, jaw, oral structures and skull. The device is to be operated and used dentists and other legally qualified professionals.
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/K200469 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200469: PAPAYA 3D Premium & PAPAYA 3D Premium Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200469
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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