510(k) · Cleared
Cleared3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J. Morita USA, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Dec 27, 2005 as substantially equivalent to K030450 (J. Morita USA, Inc., 2003) after a 98-day review. Its family tree reaches back 2 generations to 1997. 66 later devices descend from it.
- Decided
- Dec 27, 2005
- Review
- 98 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K973598 (1997). 4 ancestors in all. 66 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 1 generation backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- This deviceK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- Descendant · cites it directly · 61 of its ownK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- Descendant · 2 generations on · 27 of its ownK111152 Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · Recalled
- Descendant · 3 generations on · 24 of its ownK122981 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- Descendant · 2 generations on · 24 of its ownK073350 Scanora 3DSoredex Palodex Group OY · 2007
- Descendant · 4 generations on · 23 of its ownK131695 Rayscan a-Expert 3DRay Co., Ltd. · 2013
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · See all- K060328Planmeca Promax 3DPlanmeca Oy · 2006 · cites it directly61descendants
- K111152Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · 2 generations on27descendants
- K122981Rayscan a-Expert 3DRay Co., Ltd. · 2013 · 3 generations on24descendants
- K073350Scanora 3DSoredex Palodex Group OY · 2007 · 2 generations on24descendants
- K131695Rayscan a-Expert 3DRay Co., Ltd. · 2013 · 4 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −1 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| 0 (this device) | 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 | — |
| +2 | K111152 | Rotograph Evo 3D | Villa Sistemi Medicali S.P.A. | 2011 | 1 |
| +3 | K122981 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| +2 | K073350 | Scanora 3D | Soredex Palodex Group OY | 2007 | — |
| +4 | K131695 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 8 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 6 | 0 |
| 2017 | 3 | 0 |
| 2018 | 10 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 |
|---|---|---|---|
| * | K030450 | 3D Accu-I-Tomo Xyz Slice View TomographSummary page 1…5. Substantial Equivalency is claimed against the following device: 3D Accu-1-tomo XYZ Slice View Tomograph MCT-1 EX From J, MORITA MFG.CORP. 5 10k # K030450 1/3 6. Description of the device: The MCT-1 EX F is an X-ray C… | 2003 |
What descends from it? (66)
See all 664 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K060328 (Planmeca Oy, 2006) has gone furthest, with 61 descendants of its own.
- 5 other devices also cite its predicate K030450.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
The Model MCT-l EXF is an x-ray imaging device that acquires a 360 degree rotational sequence of the head and neck areas, including the ENT and dento-maxillofacial areas, for use in diagnostic support. The device accomplishes this task by reconstructing a three-dimensional matrix of the examined volume and producing two-dimensional views of this volume, displaying both two- and three-dimensional images. The device is operated and used by physicians, dentists, and x-ray technologists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052587 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052587: 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052587
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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