510(k) · Cleared
Recalled · 2010DVT Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imaging Sciences Intl., Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Aug 19, 2005 as substantially equivalent to K003787 (Aperio Services, LLC, 2001) and 2 other predicates after a 29-day review. Its family tree reaches back 2 generations to 1997. 12 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 19, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 2 generations to K973598 (1997). 5 ancestors in all, the oldest K945375 (1995). 12 later devices descend from it, 1 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 deviceK051980 DVT ScannerImaging Sciences Intl., Inc. · 2005
- Descendant · cites it directly · 11 of its ownK063622 Finecube Dental CTThe Yoshida Dental Mfg. Co., Ltd. · 2007
- Descendant · 2 generations on · 6 of its ownK122199 PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd. · 2013
- Descendant · 3 generations on · 2 of its ownK161881 PreXion3D ExcelsiorPrexion Corporation · 2016
- Descendant · 3 generations on · 2 of its ownK152489 ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp. · 2016
- Descendant · 2 generations on · 2 of its ownK072574 Alphard Cone Beam CT, Model X178Takara Belmont Corp. · 2007
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K063622Finecube Dental CTThe Yoshida Dental Mfg. Co., Ltd. · 2007 · cites it directly11descendants
- K122199PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd. · 2013 · 2 generations on6descendants
- K161881PreXion3D ExcelsiorPrexion Corporation · 2016 · 3 generations on2descendants
- K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp. · 2016 · 3 generations on2descendants
- K072574Alphard Cone Beam CT, Model X178Takara Belmont Corp. · 2007 · 2 generations on2descendants
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) | K051980 | DVT Scanner | Imaging Sciences Intl., Inc. | 2005 | — |
| +1 | K063622 | Finecube Dental CT | The Yoshida Dental Mfg. Co., Ltd. | 2007 | — |
| +2 | K122199 | PREXION3D Eclipse | The Yoshida Dental Mfg. Co., Ltd. | 2013 | — |
| +3 | K161881 | PreXion3D Excelsior | Prexion Corporation | 2016 | — |
| +3 | K152489 | ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray | Panoramic Corp. | 2016 | — |
| +2 | K072574 | Alphard Cone Beam CT, Model X178 | Takara Belmont Corp. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (3)
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 9000Summary page 2…QR - DVT 900 Manufacturer: NIM s.r.1. Via Silverstrini, 20 37135 Verona Italy 510 (k) Number: K003787 Device: Advantage 3-D XR Manufacturer: General Electric Medical Systems 283, rue de la… | 2001 |
| * | K945375 | Advantx LcaSummary page 2…General Electric Medical Systems 283, rue de la Miniere 78533 Buc Cedex France 510 (k) Number: K945375 Device: 3D Accu-l-tomo XYZ Slice View Tomograph Manufacturer: J. Morita Manufacturing Corporation… | 1995 |
| * | K030450 | 3D Accu-I-Tomo Xyz Slice View TomographSummary page 2…raph Manufacturer: J. Morita Manufacturing Corporation 680 Higashihama Minami-cho, Fushimi-ku Japan 510 (k) Number: K030450 Description Of The Device: The DVT Scanner is a dedicated X-Ray imaging device that acquires a 360 degree rotational X-ray sequ… | 2003 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063622 | Finecube Dental CT | 2007 | 11 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2010 | Not classified | Z-3018-2011 | Other | Recalling firm received a customer complaint regarding a defective X-ray tube head and power supply |
| Oct 30, 2009 | Not classified | Z-0543-2010 | Device Design | overhead carriage drops quickly |
| Mar 19, 2008 | Not classified | Z-1645-2008 | Error in labeling | incorrect scatter labeling |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K063622 (The Yoshida Dental Mfg. Co., Ltd., 2007) has gone furthest, with 11 descendants of its own.
- 5 other devices also cite its predicate K003787.
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 Imaging Sciences International Inc. DVT Scanner constructs a three dimensional model from images taken during a rotational X-ray sequence. The DVT Scanner is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects. The DVT Scanner is optimized for imaging of TM Joint studies, mandible & maxilla for implant planning, sinuses, the maxillofacial complex, temporal bone, etc.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051980 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051980: DVT Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051980
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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