510(k) · Cleared
ClearedGreen16/Green18 (Model: PHT-65LHS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
VATECH Co., Ltd. · OAS X-Ray, Tomography, Computed, Dental
Cleared on Jun 16, 2017 as substantially equivalent to K162660 (VATECH Co., Ltd., 2016) after a 158-day review. Its family tree reaches back 9 generations to 1997. 18 later devices descend from it.
- Decided
- Jun 16, 2017
- Review
- 158 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K973642 (1997). 10 ancestors in all. 18 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 5 generations between
- 3 generations backK122606 PHT-6500; PHT-60CFO; Pax-I3DMtechgroup · 2012
- 2 generations backK152106 Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartVATECH Co., Ltd. · 2015
- 1 generation backK162660 Green Smart (Model: PHT-35LHS)VATECH Co., Ltd. · 2016
- This deviceK170066 Green16/Green18 (Model: PHT-65LHS)VATECH Co., Ltd. · 2017
- Descendant · cites it directly · 10 of its ownK181452 RCT800Ray Co., Ltd. · 2018
- Descendant · 2 generations on · 8 of its ownK182805 RCT800Ray Co., Ltd. · 2018
- Descendant · 3 generations on · 7 of its ownK192737 RCT800Ray Co., Ltd. · 2019
- Descendant · 2 generations on · 6 of its ownK182614 RCT700Ray Co., Ltd. · 2018
- Descendant · 3 generations on · 5 of its ownK213226 RCT700Ray Co., Ltd. · 2021
Show all 9 generations
- Root · 9 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 8 generations backK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- 7 generations backK082350 PAX-500VATECH Co., Ltd. · 2008
- 6 generations backK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- 5 generations backK102259 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2011
- 4 generations backK121412 Pax-FLEX3D, PHT-7000VATECH Co., Ltd. · 2012
- 3 generations backK122606 PHT-6500; PHT-60CFO; Pax-I3DMtechgroup · 2012
- 2 generations backK152106 Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartVATECH Co., Ltd. · 2015
- 1 generation backK162660 Green Smart (Model: PHT-35LHS)VATECH Co., Ltd. · 2016
- This deviceK170066 Green16/Green18 (Model: PHT-65LHS)VATECH Co., Ltd. · 2017
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K181452RCT800Ray Co., Ltd. · 2018 · cites it directly10descendants
- K182805RCT800Ray Co., Ltd. · 2018 · 2 generations on8descendants
- K192737RCT800Ray Co., Ltd. · 2019 · 3 generations on7descendants
- K182614RCT700Ray Co., Ltd. · 2018 · 2 generations on6descendants
- K213226RCT700Ray Co., Ltd. · 2021 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −8 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| −7 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| −6 | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| −5 | K102259 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2011 | — |
| −4 | K121412 | Pax-FLEX3D, PHT-7000 | VATECH Co., Ltd. | 2012 | — |
| −3 | K122606 | PHT-6500; PHT-60CFO; Pax-I3D | Mtechgroup | 2012 | — |
| −2 | K152106 | Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart | VATECH Co., Ltd. | 2015 | — |
| −1 | K162660 | Green Smart (Model: PHT-35LHS) | VATECH Co., Ltd. | 2016 | — |
| 0 (this device) | K170066 | Green16/Green18 (Model: PHT-65LHS) | VATECH Co., Ltd. | 2017 | — |
| +1 | K181452 | RCT800 | Ray Co., Ltd. | 2018 | — |
| +2 | K182805 | RCT800 | Ray Co., Ltd. | 2018 | — |
| +3 | K192737 | RCT800 | Ray Co., Ltd. | 2019 | — |
| +2 | K182614 | RCT700 | Ray Co., Ltd. | 2018 | — |
| +3 | K213226 | RCT700 | Ray Co., Ltd. | 2021 | — |
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 |
|---|---|---|
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 5 | 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 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? (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 |
|---|---|---|---|
| * | K162660 | Green Smart (Model: PHT-35LHS)Summary page 4…Radiology 5. Predicate Device Information Manufacturer: VATECH Co., Ltd. Predicate device: Green Smart (PHT-35LHS) / K162660 Common or Usual Name: X-Ray, Tomography, Computed, Dental Regulation Classification: Computed tomography x-ray… | 2016 |
What descends from it? (18)
See all 183 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 20 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K181452 (Ray Co., Ltd., 2018) has gone furthest, with 10 descendants of its own.
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. 2017, 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?
PHT-65LHS is intended to produce panoramic, cephalometric or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, ENT, sinus and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170066: Green16/Green18 (Model: PHT-65LHS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170066
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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