DeviceClearance

Product code LLZ— Radiology

syngo Application Software

Classification name
System, Image Processing, Radiological
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Total cleared
2,286
First cleared
Most recent

Market context for product code LLZ

FDA has cleared 2,286 devices under product code LLZ between 1983 and 2026, filed by 1,040 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 LLZ

Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

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 LLZ

1–100 of 2,286

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