DeviceClearance

Product code IYN— Radiology

Lumify Diagnostic Ultrasound System

Classification name
System, Imaging, Pulsed Doppler, Ultrasonic
Device class
Class 2
Regulation
21 CFR 892.1550
Advisory panel
Radiology
Total cleared
1,182
First cleared
Most recent

Market context for product code IYN

FDA has cleared 1,182 devices under product code IYN between 1978 and 2026, filed by 253 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 IYN

Adverse events under product code IYN

product code IYN
Death
25
Injury
163
Malfunction
1,538
Other
4
Total
1,730

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 IYN

1–100 of 1,182

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