510(k) · Cleared
ClearedPAPAYA 3D 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 Dec 10, 2015 as substantially equivalent to K123381 (Cefla S.C., 2013) and 1 other predicate after a 302-day review. Its family tree reaches back 9 generations to 1997. 4 later devices descend from it.
- Decided
- Dec 10, 2015
- Review
- 302 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K973642 (1997). 14 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 5 generations between
- 3 generations backK122155 PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital…VATECH Co., Ltd. · 2012
- 2 generations backK130419 Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2013
- 1 generation backK141700 Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2014
- This deviceK150354 PAPAYA 3D PlusGenoray Co., Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK200469 PAPAYA 3D Premium & PAPAYA 3D Premium PlusGenoray Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK250060 GT300; GT300-CGenoray Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK220392 PAPAYA 3D & PAPAYA 3D PlusGenoray Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK151137 X-View, ImagenEdlen Imaging, LLC · 2016
Show all 9 generations
- Root · 9 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 8 generations backK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- 7 generations backK082350 PAX-500VATECH Co., Ltd. · 2008
- 6 generations backK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- 5 generations backK102259 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2011
- 4 generations backK113672 PCH-2500 Digital Extraoral Source X-Ray SystemVATECH Co., Ltd. · 2012
- 3 generations backK122155 PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital…VATECH Co., Ltd. · 2012
- 2 generations backK130419 Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2013
- 1 generation backK141700 Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2014
- This deviceK150354 PAPAYA 3D PlusGenoray Co., Ltd. · 2015
Most influential descendants
Showing 4 of 4 · See all- K200469PAPAYA 3D Premium & PAPAYA 3D Premium PlusGenoray Co., Ltd. · 2020 · cites it directly1descendant
- K250060GT300; GT300-CGenoray Co., Ltd. · 2025 · 2 generations on0descendants
- K220392PAPAYA 3D & PAPAYA 3D PlusGenoray Co., Ltd. · 2022 · cites it directly0descendants
- K151137X-View, ImagenEdlen Imaging, LLC · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −8 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| −7 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| −6 | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| −5 | K102259 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2011 | — |
| −4 | K113672 | PCH-2500 Digital Extraoral Source X-Ray System | VATECH Co., Ltd. | 2012 | — |
| −3 | K122155 | PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital Extraoral Source… | VATECH Co., Ltd. | 2012 | — |
| −2 | K130419 | Papaya Plus, Digital Extraoral Source X-Ray System | Genoray Co., Ltd. | 2013 | — |
| −1 | K141700 | Papaya Plus, Digital Extraoral Source X-Ray System | Genoray Co., Ltd. | 2014 | — |
| 0 (this device) | K150354 | PAPAYA 3D Plus | Genoray Co., Ltd. | 2015 | — |
| +1 | K200469 | PAPAYA 3D Premium & PAPAYA 3D Premium Plus | Genoray Co., Ltd. | 2020 | — |
| +2 | K250060 | GT300; GT300-C | Genoray Co., Ltd. | 2025 | — |
| +1 | K220392 | PAPAYA 3D & PAPAYA 3D Plus | Genoray Co., Ltd. | 2022 | — |
| +1 | K151137 | X-View, Imagen | Edlen Imaging, LLC | 2016 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K123381 | Hyperion X9Summary page 4…Device Class: Class II per regulation 21 CFR 892.1750 4. Predicate Device (Equivalent Legally Marketed Device) Hyperion X9 (K123381, Cefla S.C.) PAPAYA Plus (K141700 Genoray Co., Ltd) 5. Description of the Device PAPAYA 3D P… | 2013 |
| * | K141700 | Papaya Plus, Digital Extraoral Source X-Ray SystemSummary page 4…er regulation 21 CFR 892.1750 4. Predicate Device (Equivalent Legally Marketed Device) Hyperion X9 (K123381, Cefla S.C.) PAPAYA Plus (K141700 Genoray Co., Ltd) 5. Description of the Device PAPAYA 3D Plus is a diagnostic imaging system which consis… | 2014 |
What descends from it? (4)
3 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 18 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K200469 (Genoray Co., Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K123381.
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. 2015, 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?
PAPAYA 3D Plus is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in: (i) producing panoramic X-ray images of the maxillofacial area, for diagnostic examination of dentition (teeth), jaws and oral structures; and (ii) producing radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with the cephalometric arm; (iii) producing tomographic images of the…
Read the full statement (125 words)
PAPAYA 3D Plus is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in:
(i) producing panoramic X-ray images of the maxillofacial area, for diagnostic examination of dentition (teeth), jaws and oral structures; and
(ii) producing radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with the cephalometric arm;
(iii) producing tomographic images of the oral and maxillofacial structure, for diagnostic examination of dentition(teeth), jaws ,oral structures and some cranial bones if equipped with CBCT option.
The system accomplishes tomographic exam by acquiring a 360-degree rotational X-ray sequence of images and reconstructing a three-dimensional matrix of the examined volume, producing twodimensional views of this volume and displaying both two dimensional images and three-dimensional renderings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150354 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150354: PAPAYA 3D Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150354
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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