510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910212Substantially Equivalent

Color Doppler Option to Ai 5200 Diag Ultraso Syst

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

K910212 is the FDA 510(k) clearance record for COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST, a class I device, cleared for Acoustic Imaging Technologies Corp. on under FDA product code JYO (Knife, Ear). FDA records list 3 510(k) clearances for Acoustic Imaging Technologies Corp., from to . As of , FDA records show no recalls naming K910212.

Clearance record

Decision date
Received
(177 days to decision)
Product code
JYO Knife, Ear
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Acoustic Imaging Technologies Corp. 10027 S. 15st St., Phoenix AZ
Third party review
No

Clearances, product code JYO

Trailing 12 months

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

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