510(k) · Cleared

Cleared

Altair Model, Dei System (Diffractive Energy Imaging System)

K013291510(k) TraditionalCleared Nov 14, 200143-day reviewClass II21 CFR 892.1550

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Advanced Diagnostics, Inc. · NCS System, Imaging, Holography, Acoustic

Cleared on Nov 14, 2001 after a 43-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).

Decided: Nov 14, 2001
Review: 43 days
Class: Class II
Product code: NCS
Recalls: None
Predicates: 1

The summary cites one number, which could not be confirmed as its predicate (see the table below).

FIG. 1 — Lineage of K013291Source: FDA 510(k) database · How lineage is built

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.

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Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K100150	FDA’s K100150 is CERAMICS2IN1 Our OCR of the scanned summary read K100150, which FDA decided on May 25, 2010, after this device was decided (Nov 14, 2001), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 1 …ography Imaging System Classification Name: 0 NCS - K001510 Predicate Device: The DEI System is s@ially equivalent to the OS-2000 Optical Sonography system cleared via k100150, November 30, 2000 with the addition of on-screen measurement capability with associated calculations. Device Description: The…	Biodenta Swiss AG	2010	—

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.

How does its category compare?

All NCS devices

NCS 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	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

Diagnostic ultrasound imaging of human soft tissues

**Small parts imaging Is intended for the breast

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/K013291 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013291: Altair Model, Dei System (Diffractive Energy Imaging System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013291

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Page last updated Nov 3, 2026