510(k) · Cleared
ClearedPHT-6500; PHT-60CFO; Pax-I3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mtechgroup · OAS X-Ray, Tomography, Computed, Dental
Cleared on Nov 20, 2012 as substantially equivalent to K121412 (VATECH Co., Ltd., 2012) after an 85-day review. Its family tree reaches back 6 generations to 1997. 27 later devices descend from it.
- Decided
- Nov 20, 2012
- Review
- 85 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K973642 (1997). 7 ancestors in all. 27 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 5 generations backK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- 4 generations backK082350 PAX-500VATECH Co., Ltd. · 2008
- 3 generations backK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- 2 generations backK102259 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2011
- 1 generation backK121412 Pax-FLEX3D, PHT-7000VATECH Co., Ltd. · 2012
- This deviceK122606 PHT-6500; PHT-60CFO; Pax-I3DMtechgroup · 2012
- Descendant · cites it directly · 25 of its ownK152106 Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartVATECH Co., Ltd. · 2015
- Descendant · 2 generations on · 19 of its ownK162660 Green Smart (Model: PHT-35LHS)VATECH Co., Ltd. · 2016
- Descendant · 3 generations on · 18 of its ownK170066 Green16/Green18 (Model: PHT-65LHS)VATECH Co., Ltd. · 2017
- Descendant · 4 generations on · 10 of its ownK181452 RCT800Ray Co., Ltd. · 2018
- Descendant · 5 generations on · 8 of its ownK182805 RCT800Ray Co., Ltd. · 2018
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K152106Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartVATECH Co., Ltd. · 2015 · cites it directly25descendants
- K162660Green Smart (Model: PHT-35LHS)VATECH Co., Ltd. · 2016 · 2 generations on19descendants
- K170066Green16/Green18 (Model: PHT-65LHS)VATECH Co., Ltd. · 2017 · 3 generations on18descendants
- K181452RCT800Ray Co., Ltd. · 2018 · 4 generations on10descendants
- K182805RCT800Ray Co., Ltd. · 2018 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −5 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| −4 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| −3 | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| −2 | K102259 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2011 | — |
| −1 | K121412 | Pax-FLEX3D, PHT-7000 | VATECH Co., Ltd. | 2012 | — |
| 0 (this device) | K122606 | PHT-6500; PHT-60CFO; Pax-I3D | Mtechgroup | 2012 | — |
| +1 | K152106 | Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart | VATECH Co., Ltd. | 2015 | — |
| +2 | K162660 | Green Smart (Model: PHT-35LHS) | VATECH Co., Ltd. | 2016 | — |
| +3 | K170066 | Green16/Green18 (Model: PHT-65LHS) | VATECH Co., Ltd. | 2017 | — |
| +4 | K181452 | RCT800 | Ray Co., Ltd. | 2018 | — |
| +5 | K182805 | RCT800 | Ray Co., Ltd. | 2018 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K121412 | Pax-FLEX3D, PHT-7000Summary page 2…dicate Device: Manufacturer: Vatech Co., Ltd Device Name: PaX-Flex3D (PHT-7000) 5l10(k) Number: K 121412 Device Description: PHT-6500 (PHT-6OCFO), a dental radiographic imaging system, consists of three different image acquisitio… | 2012 |
What descends from it? (27)
See all 272 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 15 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K152106 (VATECH Co., Ltd., 2015) has gone furthest, with 25 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. 2012, 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-6500 (PHT-6OCFO) is a computed tomography x-ray system intended to produce panoramic, cephalometric 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 maxillot'acial 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K122606 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122606: PHT-6500; PHT-60CFO; Pax-I3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122606
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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