510(k) · Cleared
ClearedDental Computed Tomography X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
VATECH Co., Ltd. · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 18, 2011 as substantially equivalent to K090171 (E-Woo Technology, 2009) after a 192-day review. Its family tree reaches back 4 generations to 1997. 42 later devices descend from it.
- Decided
- Feb 18, 2011
- Review
- 192 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K973642 (1997). 5 ancestors in all. 42 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 3 generations backK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- 2 generations backK082350 PAX-500VATECH Co., Ltd. · 2008
- 1 generation backK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- This deviceK102259 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2011
- Descendant · cites it directly · 28 of its ownK121412 Pax-FLEX3D, PHT-7000VATECH Co., Ltd. · 2012
- Descendant · 2 generations on · 27 of its ownK122606 PHT-6500; PHT-60CFO; Pax-I3DMtechgroup · 2012
- Descendant · 3 generations on · 25 of its ownK152106 Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartVATECH Co., Ltd. · 2015
- Descendant · 4 generations on · 19 of its ownK162660 Green Smart (Model: PHT-35LHS)VATECH Co., Ltd. · 2016
- Descendant · 5 generations on · 18 of its ownK170066 Green16/Green18 (Model: PHT-65LHS)VATECH Co., Ltd. · 2017
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K121412Pax-FLEX3D, PHT-7000VATECH Co., Ltd. · 2012 · cites it directly28descendants
- K122606PHT-6500; PHT-60CFO; Pax-I3DMtechgroup · 2012 · 2 generations on27descendants
- K152106Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartVATECH Co., Ltd. · 2015 · 3 generations on25descendants
- K162660Green Smart (Model: PHT-35LHS)VATECH Co., Ltd. · 2016 · 4 generations on19descendants
- K170066Green16/Green18 (Model: PHT-65LHS)VATECH Co., Ltd. · 2017 · 5 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −3 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| −2 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| −1 | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| 0 (this device) | K102259 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2011 | — |
| +1 | K121412 | Pax-FLEX3D, PHT-7000 | VATECH Co., Ltd. | 2012 | — |
| +2 | K122606 | PHT-6500; PHT-60CFO; Pax-I3D | Mtechgroup | 2012 | — |
| +3 | K152106 | Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart | VATECH Co., Ltd. | 2015 | — |
| +4 | K162660 | Green Smart (Model: PHT-35LHS) | VATECH Co., Ltd. | 2016 | — |
| +5 | K170066 | Green16/Green18 (Model: PHT-65LHS) | VATECH Co., Ltd. | 2017 | — |
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 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 |
|---|---|---|---|
| * | K090171 | Computed Tomography X-Ray System, Pax-REVE3DSummary page 2…Manufacturer :E-WOO Technology Co., Ltd. Device PaX-Reve3D 5 10O(k) Number K090171 (Decision Date - 4/30/2009) Substantial Equivalence: The PaX-Flex3D described in this 510(k) has the same intend… | 2009 |
What descends from it? (42)
See all 422 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 14 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K121412 (VATECH Co., Ltd., 2012) has gone furthest, with 28 descendants of its own.
- 1 other device also cites its predicate K090171.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
PaX-Flex3D is a computed tomography x-ray system intended to produce panoramic, cephalornetric or cross-sectional images of the oral anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360' rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry .The device is operated and used by physicians, dentists, and x-ray technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102259: Dental Computed Tomography 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/K102259
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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