510(k) · Cleared
ClearedVolumetric Tomography
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentarium Dental, Inc. · OAS X-Ray, Tomography, Computed, Dental
Cleared on Jan 31, 2007 as substantially equivalent to K973642 (Instrumentarium Imaging, Inc., 1997) after a 41-day review. Its family tree reaches back 1 generation to 1997. 68 later devices descend from it.
- Decided
- Jan 31, 2007
- Review
- 41 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973642 (1997). 68 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- This deviceK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- Descendant · cites it directly · 67 of its ownK082350 PAX-500VATECH Co., Ltd. · 2008
- Descendant · 2 generations on · 59 of its ownK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- Descendant · 3 generations on · 42 of its ownK102259 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2011
- Descendant · 4 generations on · 28 of its ownK121412 Pax-FLEX3D, PHT-7000VATECH Co., Ltd. · 2012
- Descendant · 5 generations on · 27 of its ownK122606 PHT-6500; PHT-60CFO; Pax-I3DMtechgroup · 2012
Showing 5 of 68 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 68 · See all- K082350PAX-500VATECH Co., Ltd. · 2008 · cites it directly67descendants
- K090171Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009 · 2 generations on59descendants
- K102259Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2011 · 3 generations on42descendants
- K121412Pax-FLEX3D, PHT-7000VATECH Co., Ltd. · 2012 · 4 generations on28descendants
- K122606PHT-6500; PHT-60CFO; Pax-I3DMtechgroup · 2012 · 5 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| 0 (this device) | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| +1 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| +2 | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| +3 | K102259 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2011 | — |
| +4 | K121412 | Pax-FLEX3D, PHT-7000 | VATECH Co., Ltd. | 2012 | — |
| +5 | K122606 | PHT-6500; PHT-60CFO; Pax-I3D | Mtechgroup | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 6 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 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? (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 |
|---|---|---|---|
| * | K973642 | Orthopantomograph OP100 and Orthoceph OC100Summary page 3…ter May 28, 1976: Orthopantomograph® OP1 00/Orthoceph® OC1 00 with OrthoTrans linear tomography option #K973642. The comparison of characteristics supports substantial equivalence. Instrumentarium Dental Street addr… | 1997 |
What descends from it? (68)
See all 682 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?
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. 2007, 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?
Volumetric Tomography is intended to be used for producing cross-sectional (tomographic) radiographic images from the edentulous or dentate area of the jaws. The cross-sectional images provide dimensional information for dental implant planning and information about location of impacted teeth.
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/K063773 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063773: Volumetric Tomography.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063773
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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