510(k) · Cleared
ClearedComputed Tomography X-Ray System, Pax-REVE3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E-Woo Technology · OAS X-Ray, Tomography, Computed, Dental
Cleared on Apr 30, 2009 as substantially equivalent to K082350 (VATECH Co., Ltd., 2008) and 1 other predicate after a 97-day review. Its family tree reaches back 3 generations to 1997. 59 later devices descend from it.
- Decided
- Apr 30, 2009
- Review
- 97 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K973642 (1997). 4 ancestors in all. 59 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 2 generations backK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- 1 generation backK082350 PAX-500VATECH Co., Ltd. · 2008
- This deviceK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- Descendant · cites it directly · 42 of its ownK102259 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2011
- Descendant · 2 generations on · 28 of its ownK121412 Pax-FLEX3D, PHT-7000VATECH Co., Ltd. · 2012
- Descendant · 3 generations on · 27 of its ownK122606 PHT-6500; PHT-60CFO; Pax-I3DMtechgroup · 2012
- Descendant · 4 generations on · 25 of its ownK152106 Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartVATECH Co., Ltd. · 2015
- Descendant · 5 generations on · 19 of its ownK162660 Green Smart (Model: PHT-35LHS)VATECH Co., Ltd. · 2016
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K102259Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2011 · cites it directly42descendants
- K121412Pax-FLEX3D, PHT-7000VATECH Co., Ltd. · 2012 · 2 generations on28descendants
- K122606PHT-6500; PHT-60CFO; Pax-I3DMtechgroup · 2012 · 3 generations on27descendants
- K152106Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartVATECH Co., Ltd. · 2015 · 4 generations on25descendants
- K162660Green Smart (Model: PHT-35LHS)VATECH Co., Ltd. · 2016 · 5 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −2 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| −1 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| 0 (this device) | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| +1 | K102259 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2011 | — |
| +2 | K121412 | Pax-FLEX3D, PHT-7000 | VATECH Co., Ltd. | 2012 | — |
| +3 | K122606 | PHT-6500; PHT-60CFO; Pax-I3D | Mtechgroup | 2012 | — |
| +4 | K152106 | Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart | VATECH Co., Ltd. | 2015 | — |
| +5 | K162660 | Green Smart (Model: PHT-35LHS) | VATECH Co., Ltd. | 2016 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 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 OAS? 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 OAS device
- #1 K213226 RCT700score 18.0 · 13 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 |
|---|---|---|---|
| * | K082350 | PAX-500Summary page 1…redicate Device A: M anu facturer :Vatech Co., Ltd. Device :PAX-500 5 10(k) Number :K082350 Predicate Device B: Manufacturer E-WOO Technology Co., Ltd. Device… | 2008 |
| * | K070658 | Dental Digital Panoramic/3D Imaging SystemSummary page 1…Manufacturer E-WOO Technology Co., Ltd. Device :EPX-lmpla; Picasso-Trio 5 10(k) Number :K070658 4. Classifications Names & Citations: 21CFR 892.1750, OAS, X-ray, tomography, computed, dental, Class2 E-WOO Tech… | 2007 |
What descends from it? (59)
See all 592 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 12 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K102259 (VATECH Co., Ltd., 2011) has gone furthest, with 42 descendants of its own.
- 3 other devices also cite its predicate K082350.
How does its category compare?
All OAS devicesOAS X-Ray, Tomography, Computed, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OAS
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAS
144in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAS
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAS
1in 2025
MAUDE reports naming product code OAS, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 6 | 168 | 0 | 0 |
| 2012 | 7 | 110 | 0 | 0 |
| 2013 | 10 | 155 | 0 | 0 |
| 2014 | 5 | 170 | 0 | 0 |
| 2015 | 5 | 164 | 1 | 0 |
| 2016 | 12 | 154 | 0 | 0 |
| 2017 | 4 | 209 | 0 | 0 |
| 2018 | 11 | 57 | 0 | 0 |
| 2019 | 7 | 55 | 0 | 1 |
| 2020 | 9 | 113 | 0 | 0 |
| 2021 | 11 | 92 | 0 | 0 |
| 2022 | 6 | 105 | 0 | 1 |
| 2023 | 12 | 77 | 0 | 1 |
| 2024 | 4 | 129 | 0 | 2 |
| 2025 | 9 | 144 | 3 | 1 |
| 2026 | 9 | 77 | 0 | — |
What is it indicated for?
The PaX-REVE3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. 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/K090171 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090171: Computed Tomography X-Ray System, Pax-REVE3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090171
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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