510(k) · Cleared
ClearedDental Digital X-Ray Imaging 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 Apr 8, 2008 as substantially equivalent to K990528 (Sirona Dental Systems GmbH, 1999) and 1 other predicate after a 130-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.
- Decided
- Apr 8, 2008
- Review
- 130 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K990528 (1999). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K100317Digital X-Ray Imaging System (Pax-Primo) Model Pax-PrimoVATECH Co., Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990528 | Orthophos 3/3 Ceph/3 DS | Sirona Dental Systems GmbH | 1999 | — |
| 0 (this device) | K073365 | Dental Digital X-Ray Imaging System | VATECH Co., Ltd. | 2008 | — |
| +1 | K100317 | Digital X-Ray Imaging System (Pax-Primo) Model Pax-Primo | VATECH Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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? (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 |
|---|---|---|---|
| * | K990528 | Orthophos 3/3 Ceph/3 DSSummary page 1…Xray Extraoral Source Digital (code MUH) Class 2 - 872.1800 PREDICATE DEVICES: Sinora Dental Systems Digital Xray System Model Orthophos 3/3 CephI3DS - K990528 Intrumentarium Corp. Digital Xray System Model Orthoceph OClIOOD - KOO 143 9 DESCRIPTION: Vatech Model PaX-P&P is a digital pan… | 1999 |
| * | K001439 | Orthoceph OC100 D | 2000 |
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 |
|---|---|---|---|
| K100317 | Digital X-Ray Imaging System (Pax-Primo) Model Pax-Primo | 2010 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K100317 (VATECH Co., Ltd., 2010) has gone furthest, with 0 descendants of its own.
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. 2008, 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?
PaX-P&P is a digital x-ray system that uses a high resolution CCD detector for real time digital image acquisition. The system allows lower radiation dose, simple user interface, and produces high quality images. It is intended for producing diagnostic x-ray radiographic images of skull, dentition, and oral structures. The device is operated and used by physicians, dentists, and x-ray technologists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073365: Dental Digital X-Ray Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073365
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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