510(k) · Cleared
ClearedComputed Tomography X-Ray System, Model Picasso-Duo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E-Woo Technology · JAK System, X-Ray, Tomography, Computed
Cleared on Oct 9, 2009 as substantially equivalent to K082350 (VATECH Co., Ltd., 2008) and 1 other predicate after a 185-day review. Its family tree reaches back 3 generations to 1997. 3 later devices descend from it.
- Decided
- Oct 9, 2009
- Review
- 185 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K973642 (1997). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 2 generations backK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- 1 generation backK082350 PAX-500VATECH Co., Ltd. · 2008
- This deviceK090991 Computed Tomography X-Ray System, Model Picasso-DuoE-Woo Technology · 2009
- Descendant · cites it directly · 2 of its ownK102196 Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2011
- Descendant · 2 generations on · 1 of its ownK132983 Ton-95LH, Pax-I3D OrthoVATECH Co., Ltd. · 2014
- Descendant · 3 generations on · 0 of its ownK160882 PaX-i3D Green Premium (Model: PCT-90LH)VATECH Co., Ltd. · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −2 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| −1 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| 0 (this device) | K090991 | Computed Tomography X-Ray System, Model Picasso-Duo | E-Woo Technology | 2009 | — |
| +1 | K102196 | Computed Tomography X-Ray System | VATECH Co., Ltd. | 2011 | — |
| +2 | K132983 | Ton-95LH, Pax-I3D Ortho | VATECH Co., Ltd. | 2014 | — |
| +3 | K160882 | PaX-i3D Green Premium (Model: PCT-90LH) | VATECH Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | K082350 | PAX-500Summary page 1…redicate Device A: Manufacturer · VATECH Co., Ltd. Device · PaX-500 510(k) Number · K082350 (Decision Date - Oct. 10. 2008) Predicate Device B: Manufacturer · E-WOO Technology Co., Ltd.… | 2008 |
| * | K070658 | Dental Digital Panoramic/3D Imaging SystemSummary page 1…anufacturer · E-WOO Technology Co., Ltd. Device · EPX-Impla: Picasso-Trio 510(k) Number · K070658 (Decision Date - Apr. 5. 2007) E-WOO Technology Co., Ltd. 510(k) Submission - Picasso-Duo 4. Classificatio… | 2007 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102196 | Computed Tomography X-Ray System | 2011 | 2 |
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 12 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K102196 (VATECH Co., Ltd., 2011) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K082350.
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. 2009, 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 Picasso-Duo is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images(optionally with panoramic) for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090991: Computed Tomography X-Ray System, Model Picasso-Duo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090991
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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