510(k) · Cleared
ClearedAvera Model Dei System (Diffractive Energy Imaging System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Diagnostics, Inc. · NCS System, Imaging, Holography, Acoustic
Cleared on May 10, 2002 as substantially equivalent to K001510 (Advanced Diagnostics, Inc., 2000) and 1 other predicate after a 168-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- May 10, 2002
- Review
- 168 days
- Class
- Class II
- Product code
- NCS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K980423 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK980423 Sonopsy LA SystemNeovision Corp. · 1998
- This deviceK013886 Avera Model Dei System (Diffractive Energy Imaging System)Advanced Diagnostics, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980423 | Sonopsy LA System | Neovision Corp. | 1998 | — |
| 0 (this device) | K013886 | Avera Model Dei System (Diffractive Energy Imaging System) | Advanced Diagnostics, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 NCS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K001510 | OS-2000 Optical Sonography SystemSummary page 1…cial Musculoskeletal, and Peripheral ‘Vascular applications. ITechnologica! Comparison to Predicate Device: The DEI System is simildr to the predicate device (0S-2000, k001510) in that both use an lobject transducer that is coupled to the patient by use of a water-path (immersion in water 'bath or use of… | 2000 |
| * | K980423 | Sonopsy LA SystemSummary page 2…disk. This modification to the predicate involves the addition of biopsy capability. The Avera is substantially equivalent to a predicate device, the Sonopsy LA System (K 980423) in that both atlow real time image-guided biopsy within image guidance in 1 plane and an assist device to locate the plane of fo… | 1998 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All NCS devicesNCS System, Imaging, Holography, Acoustic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NCS
FDA has decided no NCS device since 2007.
Median 510(k) review, days · NCS
Too few NCS 510(k)s in any year since 2007 to give a median.
Recalls per year · NCS
No recall names NCS since 2007.
Adverse event reports per year · NCS
No MAUDE report names NCS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Diagnostic ultrasound imaging of human soft tissues
Other Indications or Modes:
1 Small organ imaging is intended for the breast
2 Breast biopsy
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/K013886 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013886: Avera Model Dei System (Diffractive Energy Imaging System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013886
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026