DeviceClearance

Product code IYO— Radiology

DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

Classification name
System, Imaging, Pulsed Echo, Ultrasonic
Device class
Class 2
Regulation
21 CFR 892.1560
Advisory panel
Radiology
Total cleared
894
First cleared
Most recent

Market context for product code IYO

FDA has cleared 894 devices under product code IYO between 1977 and 2026, filed by 375 applicant companies. 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.

Clearances per year

last 15 years

Top applicants under product code IYO

Adverse events under product code IYO

product code IYO
Malfunction
3,339
Total
3,339

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code IYO

1–100 of 894

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