510(k) · Cleared
ClearedAna-Bel, Model 087D and Ana-Bel CM, Model 187-CM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Takara Belmont USA, Inc. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Jun 2, 2004 as substantially equivalent to K900681 (Belmont Equipment Corp., 1990) and 1 other predicate after a 71-day review. Its family tree reaches back 1 generation to 1990. 4 later devices descend from it.
- Decided
- Jun 2, 2004
- Review
- 71 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K900681 (1990). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK900681 Panoramic Model X-Caliber X-RayBelmont Equipment Corp. · 1990
- This deviceK040748 Ana-Bel, Model 087D and Ana-Bel CM, Model 187-CMTakara Belmont USA, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK090020 Bel-Cypher, Model Y977Takara-Belmont Co., Ltd. · 2009
- Descendant · 2 generations on · 1 of its ownK110160 Bel-Cypher NTakara Belmont Corporation · 2011
- Descendant · 3 generations on · 0 of its ownK163175 Bel-Cypher ProTakara Belmont Corporation · 2017
- Descendant · cites it directly · 0 of its ownK062529 Belmax CM Model X168Takara Belmont USA, Inc. · 2006
Most influential descendants
Showing 4 of 4 · See all- K090020Bel-Cypher, Model Y977Takara-Belmont Co., Ltd. · 2009 · cites it directly2descendants
- K110160Bel-Cypher NTakara Belmont Corporation · 2011 · 2 generations on1descendant
- K163175Bel-Cypher ProTakara Belmont Corporation · 2017 · 3 generations on0descendants
- K062529Belmax CM Model X168Takara Belmont USA, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900681 | Panoramic Model X-Caliber X-Ray | Belmont Equipment Corp. | 1990 | — |
| 0 (this device) | K040748 | Ana-Bel, Model 087D and Ana-Bel CM, Model 187-CM | Takara Belmont USA, Inc. | 2004 | — |
| +1 | K090020 | Bel-Cypher, Model Y977 | Takara-Belmont Co., Ltd. | 2009 | — |
| +2 | K110160 | Bel-Cypher N | Takara Belmont Corporation | 2011 | — |
| +3 | K163175 | Bel-Cypher Pro | Takara Belmont Corporation | 2017 | — |
| +1 | K062529 | Belmax CM Model X168 | Takara Belmont USA, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 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 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? (2)
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.
What descends from it? (4)
2 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K090020 (Takara-Belmont Co., Ltd., 2009) has gone furthest, with 2 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?
The ANA-BEL and ANA-BEL CM dental panoramic and cephalometric X-ray system is
indicated for use as a generator of radiographic images of the dento-maxilofacial region
and is intended for dental examination and diagnosis of diseases of the teeth, jaw, and
oral structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040748 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040748: Ana-Bel, Model 087D and Ana-Bel CM, Model 187-CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040748
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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