510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092164Substantially Equivalent

Transcranial and Vascular Doppler Diagnotic Ultrasound Transducers, Model Ems-9Ua

Shenzhen Delicate Electronics Co., Ltd., Yonkers NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092164 is the FDA 510(k) clearance record for TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA, a class II device, cleared for Shenzhen Delicate Electronics Co., Ltd. on under FDA product code OQQ (Diagnostic Ultrasonic Transducer, Robotic). FDA's definition for product code OQQ reads: "Diagnostic ultrasonic imaging or monitoring". FDA records list 2 510(k) clearances for Shenzhen Delicate Electronics Co., Ltd., from to . As of , FDA records show no recalls naming K092164.

Clearance record

Decision date
Received
(301 days to decision)
Product code
OQQ Diagnostic Ultrasonic Transducer, Robotic
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
Shenzhen Delicate Electronics Co., Ltd. 1 Odell Plz., Yonkers NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OQQ

Trailing 12 months

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

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