510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013886Substantially Equivalent

Avera Model Dei System (Diffractive Energy Imaging System)

Advanced Diagnostics, Inc., Preston WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013886 is the FDA 510(k) clearance record for AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM), a class II device, cleared for Advanced Diagnostics, Inc. on under FDA product code NCS (System, Imaging, Holography, Acoustic). FDA records list 4 510(k) clearances for Advanced Diagnostics, Inc., from to . As of , FDA records show no recalls naming K013886.

Clearance record

Decision date
Received
(168 days to decision)
Product code
NCS System, Imaging, Holography, Acoustic
Regulation
21 CFR 892.1550
Device class
Class II
Review panel
Radiology
Applicant
Advanced Diagnostics, Inc. 8112 304th Ave. Se., Preston WA
510(k) summary
Summary
Third party review
No

Clearances, product code NCS

Trailing 12 months

FDA records hold no clearances under product code NCS in the trailing twelve months.

FDA records show no clearances under product code NCS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NCS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260