510(k) · Cleared
ClearedVeraviewepocs Panoramic/Cephalometric X-Ray Unit with Cephalometric
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J. Morita Mfg. Corp. · EAG Cephalometer
Cleared on May 29, 2003 as substantially equivalent to K930338 (Instrumentarium Corp., 1993) and 2 other predicates after an 84-day review. Its family tree reaches back 1 generation to 1993. 24 later devices descend from it.
- Decided
- May 29, 2003
- Review
- 84 days
- Class
- Class II
- Product code
- EAG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K930338 (1993). 3 ancestors in all. 24 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK930338 Orthoceph OC100Instrumentarium Corp. · 1993
- This deviceK030699 Veraviewepocs Panoramic/Cephalometric X-Ray Unit with CephalometricJ. Morita Mfg. Corp. · 2003
- Descendant · cites it directly · 22 of its ownK073696 VeraviewepocsJ. Morita USA, Inc. · 2008
- Descendant · 2 generations on · 21 of its ownK093683 Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010
- Descendant · 3 generations on · 11 of its ownK111231 Panoura 18SThe Yoshida Dental Mfg. Co., Ltd. · 2011
- Descendant · 3 generations on · 8 of its ownK122018 OP300Palodex Group OY · 2012
- Descendant · 4 generations on · 7 of its ownK133544 OP300Palodex Group OY · 2014
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K073696VeraviewepocsJ. Morita USA, Inc. · 2008 · cites it directly22descendants
- K093683Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010 · 2 generations on21descendants
- K111231Panoura 18SThe Yoshida Dental Mfg. Co., Ltd. · 2011 · 3 generations on11descendants
- K122018OP300Palodex Group OY · 2012 · 3 generations on8descendants
- K133544OP300Palodex Group OY · 2014 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930338 | Orthoceph OC100 | Instrumentarium Corp. | 1993 | — |
| 0 (this device) | K030699 | Veraviewepocs Panoramic/Cephalometric X-Ray Unit with Cephalometric | J. Morita Mfg. Corp. | 2003 | — |
| +1 | K073696 | Veraviewepocs | J. Morita USA, Inc. | 2008 | — |
| +2 | K093683 | Orthopantomograph OP300 | Instrumentarium Dental, Palodex Group OY | 2010 | — |
| +3 | K111231 | Panoura 18S | The Yoshida Dental Mfg. Co., Ltd. | 2011 | — |
| +3 | K122018 | OP300 | Palodex Group OY | 2012 | — |
| +4 | K133544 | OP300 | Palodex Group OY | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 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 EAG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K930338 | Orthoceph OC100Summary page 2…ses of the FDA’s medical device regulations, to Instrumentarium Corporation Imaging Division’s (i) Orthoceph OCl 00 extraoral x-ray unit for cephalometric radiography (K#930338 and K#973642), .(ii), Orthopantomograph OP 100 extraoral x-ray unit for cephalometric radiography (also cleared under K#973642),… | 1993 |
| * | K973642 | Orthopantomograph OP100 and Orthoceph OC100Summary page 2…A’s medical device regulations, to Instrumentarium Corporation Imaging Division’s (i) Orthoceph OCl 00 extraoral x-ray unit for cephalometric radiography (K#930338 and K#973642), .(ii), Orthopantomograph OP 100 extraoral x-ray unit for cephalometric radiography (also cleared under K#973642), and (iii) Ort… | 1997 |
| * | K001439 | Orthoceph OC100 D | 2000 |
What descends from it? (24)
See all 242 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 EAG devicesEAG Cephalometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EAG
FDA has decided no EAG device since 2007.
Median 510(k) review, days · EAG
Too few EAG 510(k)s in any year since 2007 to give a median.
Recalls per year · EAG
No recall names EAG since 2007.
Adverse event reports per year · EAG
2in 2023
MAUDE reports naming product code EAG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Veraviewepocs Panoramic/Cephalometric X-ray Unit With Digital Image Function is an extraoral source X-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, and oral structure by exposing an X-ray image receptor to ionizing radiation, with an optional cephalometric capability, and a digital imaging capability for taking both panoramic and cephalometric images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030699: Veraviewepocs Panoramic/Cephalometric X-Ray Unit with Cephalometric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030699
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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