510(k) · Cleared
ClearedPCH-2500 Digital Extraoral Source X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
VATECH Co., Ltd. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Mar 27, 2012 as substantially equivalent to K102259 (VATECH Co., Ltd., 2011) after a 105-day review. Its family tree reaches back 5 generations to 1997. 12 later devices descend from it.
- Decided
- Mar 27, 2012
- Review
- 105 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K973642 (1997). 6 ancestors in all. 12 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 4 generations backK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- 3 generations backK082350 PAX-500VATECH Co., Ltd. · 2008
- 2 generations backK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- 1 generation backK102259 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2011
- This deviceK113672 PCH-2500 Digital Extraoral Source X-Ray SystemVATECH Co., Ltd. · 2012
- Descendant · cites it directly · 11 of its ownK122155 PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital…VATECH Co., Ltd. · 2012
- Descendant · 2 generations on · 7 of its ownK130419 Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2013
- Descendant · 3 generations on · 6 of its ownK141700 Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2014
- Descendant · 4 generations on · 4 of its ownK150354 PAPAYA 3D PlusGenoray Co., Ltd. · 2015
- Descendant · 5 generations on · 1 of its ownK200469 PAPAYA 3D Premium & PAPAYA 3D Premium PlusGenoray Co., Ltd. · 2020
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K122155PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital Extraoral Source X-Ray SystemVATECH Co., Ltd. · 2012 · cites it directly11descendants
- K130419Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2013 · 2 generations on7descendants
- K141700Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2014 · 3 generations on6descendants
- K150354PAPAYA 3D PlusGenoray Co., Ltd. · 2015 · 4 generations on4descendants
- K200469PAPAYA 3D Premium & PAPAYA 3D Premium PlusGenoray Co., Ltd. · 2020 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −4 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| −3 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| −2 | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| −1 | K102259 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2011 | — |
| 0 (this device) | K113672 | PCH-2500 Digital Extraoral Source X-Ray System | VATECH Co., Ltd. | 2012 | — |
| +1 | 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 | — |
| +3 | K141700 | Papaya Plus, Digital Extraoral Source X-Ray System | Genoray Co., Ltd. | 2014 | — |
| +4 | K150354 | PAPAYA 3D Plus | Genoray Co., Ltd. | 2015 | — |
| +5 | K200469 | PAPAYA 3D Premium & PAPAYA 3D Premium Plus | Genoray Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 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 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 |
|---|---|---|---|
| * | K102259 | Dental Computed Tomography X-Ray SystemSummary page 2…cate Device: Manufacturer .Vatech Co., Ltd Device .PaX-Elex3D 510(k) Number K 102259 (Decision Date - 2/18/2011) Substantial Equivalence: PCH-2500 described in this 5 10(k) has the similar intended use an… | 2011 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122155 | PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital Extraoral Source X-Ray System | 2012 | 11 |
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 15 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K122155 (VATECH Co., Ltd., 2012) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K102259.
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. 2012, 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?
PCH-2500 is digital extra oral source x-ray system intended to take panoramic and cephalometric; images of the oral and maxillofacial anatomy to provide diagnostic information for adult and pediatric patients. The device should be operated and used by dentists, and x-ray technicians and other professionals licensed by the law of the state in which the device is used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113672 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113672: PCH-2500 Digital Extraoral Source X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113672
Report an extraction error
Are you the manufacturer?
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