510(k) · Cleared
ClearedOrthopantomograph OP100 and Orthoceph OC100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentarium Imaging, Inc. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Nov 21, 1997 after a 58-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 96 later devices descend from it.
- Decided
- Nov 21, 1997
- Review
- 58 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 0
96 later devices descend from it, 4 citing it directly.
- This deviceK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- Descendant · cites it directly · 68 of its ownK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- Descendant · 2 generations on · 67 of its ownK082350 PAX-500VATECH Co., Ltd. · 2008
- Descendant · 3 generations on · 59 of its ownK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- Descendant · 4 generations on · 42 of its ownK102259 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2011
- Descendant · 5 generations on · 28 of its ownK121412 Pax-FLEX3D, PHT-7000VATECH Co., Ltd. · 2012
Showing 5 of 96 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 96 · See all- K063773Volumetric TomographyInstrumentarium Dental, Inc. · 2007 · cites it directly68descendants
- K082350PAX-500VATECH Co., Ltd. · 2008 · 2 generations on67descendants
- K090171Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009 · 3 generations on59descendants
- K102259Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2011 · 4 generations on42descendants
- K121412Pax-FLEX3D, PHT-7000VATECH Co., Ltd. · 2012 · 5 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| +1 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| +2 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| +3 | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| +4 | K102259 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2011 | — |
| +5 | K121412 | Pax-FLEX3D, PHT-7000 | VATECH Co., Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 8 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 7 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 7 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EHD? 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 EHD device
- #1 K260795 Hand-held Dental X-ray System (HyperLight-M)score 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (96)
See all 964 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?
- Of its descendants, K063773 (Instrumentarium Dental, Inc., 2007) has gone furthest, with 68 descendants of its own.
How does its category compare?
All EHD devicesEHD Unit, X-Ray, Extraoral With Timer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EHD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EHD
58in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EHD
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EHD
6in 2024
MAUDE reports naming product code EHD, 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 | 1 | — | 0 | 5 |
| 2008 | 5 | 49 | 0 | 6 |
| 2009 | 4 | 92 | 0 | 38 |
| 2010 | 4 | 268 | 3 | 47 |
| 2011 | 3 | 102 | 3 | 26 |
| 2012 | 2 | — | 0 | 22 |
| 2013 | 4 | 216 | 0 | 21 |
| 2014 | 3 | 107 | 1 | 20 |
| 2015 | 1 | — | 0 | 110 |
| 2016 | 2 | — | 1 | 63 |
| 2017 | 4 | 28 | 1 | 66 |
| 2018 | 5 | 30 | 0 | 21 |
| 2019 | 4 | 173 | 0 | 21 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 8 | 58 | 0 | 4 |
| 2023 | 8 | 147 | 0 | 2 |
| 2024 | 7 | 58 | 0 | 6 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 6 | 128 | 0 | — |
What is it indicated for?
Orthopantomograph® OP100 and Orthoceph® OC100 are intended to be used for producing diagnostic x-ray radiographs of dentition, TM-joints and skull. Ortho Trans option produces cross-sectional and lateral images of dental arch using linear tomographic method.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973642 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973642: Orthopantomograph OP100 and Orthoceph OC100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973642
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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