510(k) · Cleared
ClearedHitachi CB Mercuray Dental Cone-Beam X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Medical Systems America, Inc. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Oct 20, 2003 as substantially equivalent to K003787 (Aperio Services, LLC, 2001) after a 13-day review. Its family tree reaches back 1 generation to 2001. 18 later devices descend from it.
- Decided
- Oct 20, 2003
- Review
- 13 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003787 (2001). 18 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK003787 Newtom QR-DVT 9000Aperio Services, LLC · 2001
- This deviceK033248 Hitachi CB Mercuray Dental Cone-Beam X-Ray SystemHitachi Medical Systems America, Inc. · 2003
- Descendant · cites it directly · 17 of its ownK060892 GalileosSirona Dental Systems GmbH · 2006
- Descendant · 2 generations on · 13 of its ownK123070 Galileos FamilySirona Dental Systems GmbH · 2013
- Descendant · 2 generations on · 7 of its ownK103711 Orthophos XG 3D / CephSirona Dental Systems GmbH · 2011
- Descendant · 3 generations on · 6 of its ownK133620 Cone Beam 3D and 2D Panoramic Dental Imaging SystemImaging Sciences International · 2014
- Descendant · 3 generations on · 5 of its ownK150217 Orthophos SLSirona Dental Systems GmbH · 2015
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K060892GalileosSirona Dental Systems GmbH · 2006 · cites it directly17descendants
- K123070Galileos FamilySirona Dental Systems GmbH · 2013 · 2 generations on13descendants
- K103711Orthophos XG 3D / CephSirona Dental Systems GmbH · 2011 · 2 generations on7descendants
- K133620Cone Beam 3D and 2D Panoramic Dental Imaging SystemImaging Sciences International · 2014 · 3 generations on6descendants
- K150217Orthophos SLSirona Dental Systems GmbH · 2015 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003787 | Newtom QR-DVT 9000 | Aperio Services, LLC | 2001 | — |
| 0 (this device) | K033248 | Hitachi CB Mercuray Dental Cone-Beam X-Ray System | Hitachi Medical Systems America, Inc. | 2003 | — |
| +1 | K060892 | Galileos | Sirona Dental Systems GmbH | 2006 | — |
| +2 | K123070 | Galileos Family | Sirona Dental Systems GmbH | 2013 | — |
| +2 | K103711 | Orthophos XG 3D / Ceph | Sirona Dental Systems GmbH | 2011 | — |
| +3 | K133620 | Cone Beam 3D and 2D Panoramic Dental Imaging System | Imaging Sciences International | 2014 | — |
| +3 | K150217 | Orthophos SL | Sirona Dental Systems GmbH | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K003787 | Newtom QR-DVT 9000 | 2001 |
What descends from it? (18)
See all 182 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 MUH devicesMUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Hitachi CB MercuRay system is an x-ray imaging device that uses a cone beam with a 360° rotational sequence, providing two-dimensional images and three-dimensional volume reconstructions. The system specifically images the head and neck areas, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033248 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033248: Hitachi CB Mercuray Dental Cone-Beam X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033248
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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