510(k) · Cleared
Cleared3D Accuitomo 150N
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J. Morita USA, Inc. · OAS X-Ray, Tomography, Computed, Dental
Cleared on Feb 18, 2021 as substantially equivalent to K171012 (J. Morita USA, Inc., 2017) after a 268-day review. Its family tree reaches back 9 generations to 1997.
- Decided
- Feb 18, 2021
- Review
- 268 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K973598 (1997). 17 ancestors in all, the oldest K930338 (1993). No later device cites it as a predicate yet.
- Root · 9 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations between
- 3 generations backK122018 OP300Palodex Group OY · 2012
- 2 generations backK133544 OP300Palodex Group OY · 2014
- 1 generation backK171012 Veraview X800J. Morita USA, Inc. · 2017
- This deviceK201378 3D Accuitomo 150NJ. Morita USA, Inc. · 2021
Show all 9 generations
- Root · 9 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 8 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 7 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 6 generations backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- 5 generations backK073350 Scanora 3DSoredex Palodex Group OY · 2007
- 4 generations backK093683 Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010
- 3 generations backK122018 OP300Palodex Group OY · 2012
- 2 generations backK133544 OP300Palodex Group OY · 2014
- 1 generation backK171012 Veraview X800J. Morita USA, Inc. · 2017
- This deviceK201378 3D Accuitomo 150NJ. Morita USA, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −8 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −7 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −6 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| −5 | K073350 | Scanora 3D | Soredex Palodex Group OY | 2007 | — |
| −4 | K093683 | Orthopantomograph OP300 | Instrumentarium Dental, Palodex Group OY | 2010 | — |
| −3 | K122018 | OP300 | Palodex Group OY | 2012 | — |
| −2 | K133544 | OP300 | Palodex Group OY | 2014 | — |
| −1 | K171012 | Veraview X800 | J. Morita USA, Inc. | 2017 | — |
| 0 (this device) | K201378 | 3D Accuitomo 150N | J. Morita USA, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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 OAS? 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 OAS device
- #1 K213226 RCT700score 18.0 · 13 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 |
|---|---|---|---|
| * | K171012 | Veraview X800Summary page 5…ce is substantially equivalent for purposes of FDA medical device regulations to the following predicate device: Trade or Proprietary Name: Veraview X800 (K#171012) Common Name: Dental Computed Tomography X-ray System imaging Classification Name: Comput… | 2017 |
| † | K073696 | Veraviewepocs | 2008 |
| † | K073695 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1F8/F17 | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 17 ancestors have a recall of any class.
How does its category compare?
All OAS devicesOAS X-Ray, Tomography, Computed, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · OAS
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAS
144in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAS
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAS
1in 2025
MAUDE reports naming product code OAS, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 6 | 168 | 0 | 0 |
| 2012 | 7 | 110 | 0 | 0 |
| 2013 | 10 | 155 | 0 | 0 |
| 2014 | 5 | 170 | 0 | 0 |
| 2015 | 5 | 164 | 1 | 0 |
| 2016 | 12 | 154 | 0 | 0 |
| 2017 | 4 | 209 | 0 | 0 |
| 2018 | 11 | 57 | 0 | 0 |
| 2019 | 7 | 55 | 0 | 1 |
| 2020 | 9 | 113 | 0 | 0 |
| 2021 | 11 | 92 | 0 | 0 |
| 2022 | 6 | 105 | 0 | 1 |
| 2023 | 12 | 77 | 0 | 1 |
| 2024 | 4 | 129 | 0 | 2 |
| 2025 | 9 | 144 | 3 | 1 |
| 2026 | 9 | 77 | 0 | — |
What is it indicated for?
The 3D Accuitomo 150N Model X800N is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography. The 3D Accuitomo 150N Model X800N is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the ENT, dento-maxillofacial areas, and hand for maturity…
Read the full statement (129 words)
The 3D Accuitomo 150N Model X800N is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography.
The 3D Accuitomo 150N Model X800N is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the ENT, dento-maxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation.
The device uses a cone shaped X-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations.
The device is to be operated and used by medical doctors, dentists, and other legally qualified professionals for pediatric and adult patients.
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/K201378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201378: 3D Accuitomo 150N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201378
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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