510(k) · Cleared
ClearedPicasso Master, Ect and Master 3D
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 Aug 21, 2008 as substantially equivalent to K070658 (E-Woo Technology, 2007) and 1 other predicate after a 52-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Aug 21, 2008
- Review
- 52 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K973598 (1997). 6 ancestors in all. No later device cites it as a predicate yet.
- 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 backK061284 I-Cat ScannerImaging Sciences Intl., Inc. · 2006 · Recalled
- This deviceK081847 Picasso Master, Ect and Master 3DE-Woo Technology · 2008
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 | K061284 | I-Cat Scanner | Imaging Sciences Intl., Inc. | 2006 | 2 |
| 0 (this device) | K081847 | Picasso Master, Ect and Master 3D | E-Woo Technology | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K070658 | Dental Digital Panoramic/3D Imaging SystemSummary page 1…em 2. Equivalent legally marketed device: This product is similar in design and identical in function to E-Woo's computed tomography X-ray system Model EPX-Impla (K070658, E-Woo Technology Co., Ltd.), Extraoral Source X-ray System, Model i-CAT Scanner (K061284, Imaging Science International Inc.)… | 2007 |
| * | K061284 | I-Cat ScannerSummary page 1…in function to E-Woo's computed tomography X-ray system Model EPX-Impla (K070658, E-Woo Technology Co., Ltd.), Extraoral Source X-ray System, Model i-CAT Scanner (K061284, Imaging Science International Inc.) 3. Indications for Use (intended use): "Picasso-Master also known as ECT and Master3D" i… | 2006 |
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 11 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 3 other devices also cite its predicate K070658.
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?
"Picasso-Master also known as ECT and Master3D" is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures for surgical planning of oral and maxillofacial area by acquiring 3600 rotational image sequences of the head and neck areas, including the ENT and dentomaxillofacial area. The device is operated and used by physicians, dentists, and x-ray technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081847 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081847: Picasso Master, Ect and Master 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081847
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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