510(k) · Cleared
ClearedPAPAYA & PAPAYA Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genoray Co., Ltd. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on May 19, 2022 as substantially equivalent to K141700 (Genoray Co., Ltd., 2014) after a 94-day review. Its family tree reaches back 9 generations to 1997.
- Decided
- May 19, 2022
- Review
- 94 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K973642 (1997). 13 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK220423 PAPAYA & PAPAYA PlusGenoray Co., Ltd. · 2022
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 deviceK220423 PAPAYA & PAPAYA PlusGenoray Co., Ltd. · 2022
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) | K220423 | PAPAYA & PAPAYA Plus | Genoray Co., Ltd. | 2022 | — |
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 |
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 MUH? 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 MUH device
- #1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 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 |
|---|---|---|---|
| * | K141700 | Papaya Plus, Digital Extraoral Source X-Ray SystemSummary page 4…Regulation Number: 21 CFR 872.1800 Device Class: Class II 4. Predicate Device (Equivalent Legally Marketed Device) Trade Name / Proprietary Name: PAPAYA Plus (K141700, GENORAY Co., Ltd) Common Name: Digital X-ray Imaging System Classification Name / Product Code: Extraoral Source X-ray Sys… | 2014 |
| † | K103182 | Triana, Picture Archiving and Communications System | 2011 |
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 25 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- None of the 13 ancestors has a recall.
- 1 other device also cites its predicate K141700.
How does its category compare?
All MUH devicesMUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MUH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUH
159in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUH
1in 2025
MAUDE reports naming product code MUH, 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 | 11 | 48 | 0 | 0 |
| 2008 | 8 | 64 | 1 | 0 |
| 2009 | 9 | 88 | 2 | 12 |
| 2010 | 9 | 174 | 0 | 9 |
| 2011 | 10 | 89 | 0 | 0 |
| 2012 | 9 | 81 | 0 | 5 |
| 2013 | 9 | 172 | 1 | 1 |
| 2014 | 8 | 168 | 1 | 5 |
| 2015 | 12 | 111 | 1 | 3 |
| 2016 | 6 | 47 | 0 | 1 |
| 2017 | 9 | 84 | 0 | 4 |
| 2018 | 3 | 29 | 0 | 10 |
| 2019 | 5 | 64 | 0 | 6 |
| 2020 | 5 | 36 | 0 | 0 |
| 2021 | 10 | 80 | 0 | 1 |
| 2022 | 7 | 57 | 0 | 0 |
| 2023 | 11 | 57 | 0 | 1 |
| 2024 | 4 | 144 | 0 | 0 |
| 2025 | 3 | 159 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
PAPAYA & PAPAYA Plus are digital extraoral source X-ray system intended to produce panoramic and cephalometric(option) images of the oral and craniofacial anatomy for a precise treatment planning in adult and pediatric care. The system is used for dental & skull radiographic examination and diagnosis of teeth, jaw, oral structure, and skull by exposing an X-ray image receptor to ionizing radiation, with a digital imaging capability for taking both…
Read the full statement (105 words)
PAPAYA & PAPAYA Plus are digital extraoral source X-ray system intended to produce panoramic and cephalometric(option) images of the oral and craniofacial anatomy for a precise treatment planning in adult and pediatric care. The system is used for dental & skull radiographic examination and diagnosis of teeth, jaw, oral structure, and skull by exposing an X-ray image receptor to ionizing radiation, with a digital imaging capability for taking both panoramic and cephalometric images. And This system can be equipped cust(Tomographic) option, which is capable of taking cross-sectional radiographic images. These images provide dimensional information for dental implant planning and information about location of impacted tecth.
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/K220423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220423: PAPAYA & PAPAYA Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220423
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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