510(k) · Cleared
ClearedX-View, Imagen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edlen Imaging, LLC · OAS X-Ray, Tomography, Computed, Dental
Cleared on Jun 7, 2016 as substantially equivalent to K060328 (Planmeca Oy, 2006) and 1 other predicate after a 405-day review. Its family tree reaches back 10 generations to 1997.
- Decided
- Jun 7, 2016
- Review
- 405 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K973642 (1997). 21 ancestors in all, the oldest K973598 (1997). No later device cites it as a predicate yet.
- Root · 10 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 6 generations between
- 3 generations backK130419 Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2013
- 2 generations backK141700 Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2014
- 1 generation backK150354 PAPAYA 3D PlusGenoray Co., Ltd. · 2015
- This deviceK151137 X-View, ImagenEdlen Imaging, LLC · 2016
Show all 10 generations
- Root · 10 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 9 generations backK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- 8 generations backK082350 PAX-500VATECH Co., Ltd. · 2008
- 7 generations backK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- 6 generations backK102259 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2011
- 5 generations backK113672 PCH-2500 Digital Extraoral Source X-Ray SystemVATECH Co., Ltd. · 2012
- 4 generations backK122155 PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital…VATECH Co., Ltd. · 2012
- 3 generations backK130419 Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2013
- 2 generations backK141700 Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2014
- 1 generation backK150354 PAPAYA 3D PlusGenoray Co., Ltd. · 2015
- This deviceK151137 X-View, ImagenEdlen Imaging, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −9 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| −8 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| −7 | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| −6 | K102259 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2011 | — |
| −5 | K113672 | PCH-2500 Digital Extraoral Source X-Ray System | VATECH Co., Ltd. | 2012 | — |
| −4 | K122155 | PCH-2500 Digital Extraoral Source X-Ray System Pax-I Digital Extraoral Source… | VATECH Co., Ltd. | 2012 | — |
| −3 | K130419 | Papaya Plus, Digital Extraoral Source X-Ray System | Genoray Co., Ltd. | 2013 | — |
| −2 | K141700 | Papaya Plus, Digital Extraoral Source X-Ray System | Genoray Co., Ltd. | 2014 | — |
| −1 | K150354 | PAPAYA 3D Plus | Genoray Co., Ltd. | 2015 | — |
| 0 (this device) | K151137 | X-View, Imagen | Edlen Imaging, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K060328 | Planmeca Promax 3DSummary page 4…ode: OAS, MUH Predicate Device: Planmeca ProMax Classification Name: Extraoral source x-ray system Class: II 510K Number: K060328 Product Code: MUH Predicate Device: Papaya 3D Plus Classification Name: X-ray, tomography, computed, dental C… | 2006 |
| * | K150354 | PAPAYA 3D Plus Cleared while this submission was under review Summary page 4…ode: MUH Predicate Device: Papaya 3D Plus Classification Name: X-ray, tomography, computed, dental Class: II 510K Number: K150354 Product Code: OAS Regulation Number: 21 CFR 892.1750 Product Description X-VIEW, IMAGEN is a 3-dimensional CBCT… | 2015 |
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 19 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 21 ancestors has a recall of any class.
- 6 other devices also cite its predicate K060328.
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. 2016, 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 X-VIEW, IMAGEN, a panoramic x-ray imaging system with cephalometric capabilities, is an extraoral source x-ray system intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry. It has the capability of using cone beam volumetric technology techniques to generate dento-maxillofacial 3D images. The device uses a cone shaped x-ray…
Read the full statement (113 words)
The X-VIEW, IMAGEN, a panoramic x-ray imaging system with cephalometric capabilities, is an extraoral source x-ray system intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry. It has the capability of using cone beam volumetric technology techniques to generate dento-maxillofacial 3D images. The device uses a cone shaped x-ray beam projected onto a flat panel detector, and the examined volume image is reconstructed to be viewed via 3D viewing stations. 2D Images are obtained using the standard narrow beam technique. The device is to be operated and used by dentists, radiologists and other legally qualified health care professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151137: X-View, Imagen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151137
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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