510(k) · Cleared
ClearedPanoramic Model X-Caliber X-Ray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Belmont Equipment Corp. · EAP Unit, X-Ray, Intraoral
Cleared on May 23, 1990 after a 100-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- May 23, 1990
- Review
- 100 days
- Class
- Class II
- Product code
- EAP
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK900681 Panoramic Model X-Caliber X-RayBelmont Equipment Corp. · 1990
- Descendant · cites it directly · 4 of its ownK040748 Ana-Bel, Model 087D and Ana-Bel CM, Model 187-CMTakara Belmont USA, Inc. · 2004
- Descendant · 2 generations on · 2 of its ownK090020 Bel-Cypher, Model Y977Takara-Belmont Co., Ltd. · 2009
- Descendant · 3 generations on · 1 of its ownK110160 Bel-Cypher NTakara Belmont Corporation · 2011
- Descendant · 4 generations on · 0 of its ownK163175 Bel-Cypher ProTakara Belmont Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK062529 Belmax CM Model X168Takara Belmont USA, Inc. · 2006
Most influential descendants
Showing 5 of 5 · See all- K040748Ana-Bel, Model 087D and Ana-Bel CM, Model 187-CMTakara Belmont USA, Inc. · 2004 · cites it directly4descendants
- K090020Bel-Cypher, Model Y977Takara-Belmont Co., Ltd. · 2009 · 2 generations on2descendants
- K110160Bel-Cypher NTakara Belmont Corporation · 2011 · 3 generations on1descendant
- K163175Bel-Cypher ProTakara Belmont Corporation · 2017 · 4 generations on0descendants
- K062529Belmax CM Model X168Takara Belmont USA, Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900681 | Panoramic Model X-Caliber X-Ray | Belmont Equipment Corp. | 1990 | — |
| +1 | K040748 | Ana-Bel, Model 087D and Ana-Bel CM, Model 187-CM | Takara Belmont USA, Inc. | 2004 | — |
| +2 | K090020 | Bel-Cypher, Model Y977 | Takara-Belmont Co., Ltd. | 2009 | — |
| +3 | K110160 | Bel-Cypher N | Takara Belmont Corporation | 2011 | — |
| +4 | K163175 | Bel-Cypher Pro | Takara Belmont Corporation | 2017 | — |
| +2 | K062529 | Belmax CM Model X168 | Takara Belmont USA, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EAP? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040748 | Ana-Bel, Model 087D and Ana-Bel CM, Model 187-CM | 2004 | 4 |
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, K040748 (Takara Belmont USA, Inc., 2004) has gone furthest, with 4 descendants of its own.
How does its category compare?
All EAP devicesEAP Unit, X-Ray, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EAP
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · EAP
Too few EAP 510(k)s in any year since 2007 to give a median.
Recalls per year · EAP
3in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EAP
1in 2025
MAUDE reports naming product code EAP, 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 | 6 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 3 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K900681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K900681: Panoramic Model X-Caliber X-Ray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900681
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026