510(k) · Cleared
ClearedVeraviewepocs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J. Morita USA, Inc. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Apr 8, 2008 as substantially equivalent to K030699 (J. Morita Mfg. Corp., 2003) and 2 other predicates after a 99-day review. Its family tree reaches back 4 generations to 1997. 22 later devices descend from it.
- Decided
- Apr 8, 2008
- Review
- 99 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K973598 (1997). 10 ancestors in all, the oldest K930338 (1993). 22 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 3 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 2 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 1 generation backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- This deviceK073696 VeraviewepocsJ. Morita USA, Inc. · 2008
- Descendant · cites it directly · 21 of its ownK093683 Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010
- Descendant · 2 generations on · 11 of its ownK111231 Panoura 18SThe Yoshida Dental Mfg. Co., Ltd. · 2011
- Descendant · 2 generations on · 8 of its ownK122018 OP300Palodex Group OY · 2012
- Descendant · 3 generations on · 7 of its ownK133544 OP300Palodex Group OY · 2014
- Descendant · 3 generations on · 6 of its ownK122199 PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd. · 2013
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K093683Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010 · cites it directly21descendants
- K111231Panoura 18SThe Yoshida Dental Mfg. Co., Ltd. · 2011 · 2 generations on11descendants
- K122018OP300Palodex Group OY · 2012 · 2 generations on8descendants
- K133544OP300Palodex Group OY · 2014 · 3 generations on7descendants
- K122199PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd. · 2013 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −3 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −2 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −1 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| 0 (this device) | K073696 | Veraviewepocs | J. Morita USA, Inc. | 2008 | — |
| +1 | K093683 | Orthopantomograph OP300 | Instrumentarium Dental, Palodex Group OY | 2010 | — |
| +2 | K111231 | Panoura 18S | The Yoshida Dental Mfg. Co., Ltd. | 2011 | — |
| +2 | K122018 | OP300 | Palodex Group OY | 2012 | — |
| +3 | K133544 | OP300 | Palodex Group OY | 2014 | — |
| +3 | K122199 | PREXION3D Eclipse | The Yoshida Dental Mfg. Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MUH? 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 MUH device
- #1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K030699 | Veraviewepocs Panoramic/Cephalometric X-Ray Unit with CephalometricSummary page 1…2.1800) Product Code: M1JH 5. Substantial Equivalency is claimed against the following devices: Veraviewepocs VE (K030699) 3D Accu-I-tomno XYZ Slice View Tomograph (K0525 87) ProMax3D (K060328)… | 2003 |
| * | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfSummary page 1…stantial Equivalency is claimed against the following devices: Veraviewepocs VE (K030699) 3D Accu-I-tomno XYZ Slice View Tomograph (K0525 87) ProMax3D (K060328) 1 /4 === Page 2 ==… | 2005 |
| * | K060328 | Planmeca Promax 3DSummary page 1…Veraviewepocs VE (K030699) 3D Accu-I-tomno XYZ Slice View Tomograph (K0525 87) ProMax3D (K060328) 1 /4 ~scription of the device:. viewepocs ( Model X550) is ext… | 2006 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093683 | Orthopantomograph OP300 | 2010 | 21 |
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 11 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K093683 (Instrumentarium Dental, Palodex Group OY, 2010) has gone furthest, with 21 descendants of its own.
- 1 other device also cites its predicate K030699.
How does its category compare?
All MUH devicesMUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MUH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUH
159in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUH
1in 2025
MAUDE reports naming product code MUH, 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 | 11 | 48 | 0 | 0 |
| 2008 | 8 | 64 | 1 | 0 |
| 2009 | 9 | 88 | 2 | 12 |
| 2010 | 9 | 174 | 0 | 9 |
| 2011 | 10 | 89 | 0 | 0 |
| 2012 | 9 | 81 | 0 | 5 |
| 2013 | 9 | 172 | 1 | 1 |
| 2014 | 8 | 168 | 1 | 5 |
| 2015 | 12 | 111 | 1 | 3 |
| 2016 | 6 | 47 | 0 | 1 |
| 2017 | 9 | 84 | 0 | 4 |
| 2018 | 3 | 29 | 0 | 10 |
| 2019 | 5 | 64 | 0 | 6 |
| 2020 | 5 | 36 | 0 | 0 |
| 2021 | 10 | 80 | 0 | 1 |
| 2022 | 7 | 57 | 0 | 0 |
| 2023 | 11 | 57 | 0 | 1 |
| 2024 | 4 | 144 | 0 | 0 |
| 2025 | 3 | 159 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Veraviewepocs is an extraoral source x-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, oral structure, TM-joints and skull including the ENT and dento-maxillofacial areas, by exposing an X-ray image receptor to ionizing radiation. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations.
The device is to be operated and used by dentists and other legally qualified professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073696 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073696: Veraviewepocs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073696
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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