510(k) · Cleared
Cleared3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1F8/F17
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 Apr 9, 2008 as substantially equivalent to K052587 (J. Morita USA, Inc., 2005) after a 100-day review. Its family tree reaches back 3 generations to 1997. 5 later devices descend from it.
- Decided
- Apr 9, 2008
- Review
- 100 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K973598 (1997). 5 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 2 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 1 generation backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- This deviceK073695 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1F8/F17J. Morita USA, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK110839 Scanora 3DSoredex Palodex Group OY · 2011
- Descendant · 2 generations on · 2 of its ownK163423 Orthopantomograph OP300Palodex Group OY · 2017 · Recalled
- Descendant · 3 generations on · 1 of its ownK230505 Orthopantomograph™ OP 3D LXPalodex Group OY · 2023
- Descendant · 4 generations on · 0 of its ownK241249 Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX…Palodex Group OY · 2024
- Descendant · 2 generations on · 0 of its ownK130297 Scanora 3DXPalodex Group OY · 2013
Most influential descendants
Showing 5 of 5 · See all- K110839Scanora 3DSoredex Palodex Group OY · 2011 · cites it directly4descendants
- K163423Orthopantomograph OP300Palodex Group OY · 2017 · 2 generations on2descendants
- K230505Orthopantomograph™ OP 3D LXPalodex Group OY · 2023 · 3 generations on1descendant
- K241249Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)Palodex Group OY · 2024 · 4 generations on0descendants
- K130297Scanora 3DXPalodex Group OY · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −2 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −1 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| 0 (this device) | K073695 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1F8/F17 | J. Morita USA, Inc. | 2008 | — |
| +1 | K110839 | Scanora 3D | Soredex Palodex Group OY | 2011 | — |
| +2 | K163423 | Orthopantomograph OP300 | Palodex Group OY | 2017 | 1 |
| +3 | K230505 | Orthopantomograph™ OP 3D LX | Palodex Group OY | 2023 | — |
| +4 | K241249 | Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) | Palodex Group OY | 2024 | — |
| +2 | K130297 | Scanora 3DX | Palodex Group OY | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 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 |
|---|---|---|---|
| * | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfSummary page 2…Table-A Actual model numbers in MCT-1EX-1F8/F17 5. Substantial Equivalency is claimed against the following devices: 3D Accu-I-tomo XYZ Slice View Tomograph MCT-1EXF (K052587) 6. Description of the device: The MCT-1EX-1F8/F17 is an x-ray imaging device that acquires 360 degree rotational sequence of t… | 2005 |
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 |
|---|---|---|---|
| K110839 | Scanora 3D | 2011 | 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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K110839 (Soredex Palodex Group OY, 2011) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K052587.
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. 2008, this device’s year, is highlighted.
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*1EX-1F8/F17 is a 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K073695 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073695: 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1F8/F17.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073695
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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