DeviceClearance

Product code OQQ— Radiology

TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA

Classification name
Diagnostic Ultrasonic Transducer, Robotic
Device class
Class 2
Regulation
21 CFR 892.1570
Advisory panel
Radiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Diagnostic ultrasonic imaging or monitoring.”

— U.S. Food and Drug Administration, device classification record for product code OQQ under 21 CFR 892.1570, via openFDA

Market context for product code OQQ

FDA has cleared 1 device under product code OQQ, all in 2010, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OQQ

Recent clearances under product code OQQ

Data sourced from openFDA. This site is unofficial and independent of the FDA.