510(k) · Cleared
ClearedPCH-2500 Digital Extraoral Source X-Ray System, Pax-I 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 Jul 15, 2013 as substantially equivalent to K122155 (VATECH Co., Ltd., 2012) after a 132-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Jul 15, 2013
- Review
- 132 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K973642 (1997). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 6 generations backK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- 5 generations backK082350 PAX-500VATECH Co., Ltd. · 2008
- 4 generations backK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- 3 generations backK102259 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2011
- 2 generations backK113672 PCH-2500 Digital Extraoral Source X-Ray SystemVATECH Co., Ltd. · 2012
- 1 generation backK122155 PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital…VATECH Co., Ltd. · 2012
- This deviceK130585 PCH-2500 Digital Extraoral Source X-Ray System, Pax-I Digital…VATECH Co., Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −6 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| −5 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| −4 | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| −3 | K102259 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2011 | — |
| −2 | 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 | — |
| 0 (this device) | K130585 | PCH-2500 Digital Extraoral Source X-Ray System, Pax-I Digital Extraoral Source… | VATECH Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K122155 | PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital Extraoral Source X-Ray SystemSummary page 7…outcome of an expert review of image comparisons for both devices, we can claim the substantial equivalence of PCH-2500 in comparison with its predicate device, PCH-2500(K122155), in terms of safety and effectiveness. Safety, EMVC and Performance Data: Electrical, mechanical, environmental safety and per… | 2012 |
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 16 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K122155.
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. 2013, 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 a 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 states in which the device is used.
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/K130585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130585: PCH-2500 Digital Extraoral Source X-Ray System, Pax-I 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/K130585
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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