510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K883845Substantially Equivalent

Resubmitted Ai 5200 Ultrasound Transducer

Phoenix Imaging, Tempe AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883845 is the FDA 510(k) clearance record for RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER, a class II device, cleared for Phoenix Imaging on under FDA product code DXK (Echocardiograph). FDA records list 2 510(k) clearances for Phoenix Imaging, from to . As of , FDA records show no recalls naming K883845.

Clearance record

Decision date
Received
(144 days to decision)
Product code
DXK Echocardiograph
Regulation
21 CFR 870.2330
Device class
Class II
Review panel
Cardiovascular
Applicant
Phoenix Imaging 4666 S. Ash Ave., Tempe AZ
Third party review
No

Clearances, product code DXK

Trailing 12 months

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

FDA records show no clearances under product code DXK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXK, 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