510(k) · Cleared
ClearedVeraviewepocs Panoramic X-Ray Unit with Cephalometric Capability
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J. Morita USA, Inc. · EAG Cephalometer
Cleared on Jun 7, 2002 as substantially equivalent to K930338 (Instrumentarium Corp., 1993) and 2 other predicates after a 38-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jun 7, 2002
- Review
- 38 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. No later device cites it as a predicate yet.
- Root · 1 generation backK930338 Orthoceph OC100Instrumentarium Corp. · 1993
- This deviceK021372 Veraviewepocs Panoramic X-Ray Unit with Cephalometric CapabilityJ. Morita USA, Inc. · 2002
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) | K021372 | Veraviewepocs Panoramic X-Ray Unit with Cephalometric Capability | J. Morita USA, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 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…redicate device, Instrumentarium Corporation Imaging Division’s Orthopantomograph OP 100, and particularly the upgraded ORTHOCEPH OC 100 for cephalometric radiography (K#930338, 973642, and 001439). The modified Veraviewepocs has the same general intended use, similar principles of operation, and similar… | 1993 |
| * | K973642 | Orthopantomograph OP100 and Orthoceph OC100Summary page 2…device, Instrumentarium Corporation Imaging Division’s Orthopantomograph OP 100, and particularly the upgraded ORTHOCEPH OC 100 for cephalometric radiography (K#930338, 973642, and 001439). The modified Veraviewepocs has the same general intended use, similar principles of operation, and similar technolo… | 1997 |
| * | K001439 | Orthoceph OC100 DSummary page 2…trumentarium Corporation Imaging Division’s Orthopantomograph OP 100, and particularly the upgraded ORTHOCEPH OC 100 for cephalometric radiography (K#930338, 973642, and 001439). The modified Veraviewepocs has the same general intended use, similar principles of operation, and similar technological charac… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K930338.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021372 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021372: Veraviewepocs Panoramic X-Ray Unit with Cephalometric Capability.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021372
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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