DeviceClearance

Product code JAA— Radiology

CombiDiagnost R90

Classification name
System, X-Ray, Fluoroscopic, Image-Intensified
Device class
Class 2
Regulation
21 CFR 892.1650
Advisory panel
Radiology
Total cleared
300
First cleared
Most recent

Market context for product code JAA

FDA has cleared 300 devices under product code JAA between 1976 and 2026, filed by 158 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 JAA

Adverse events under product code JAA

product code JAA
Other
1
Total
1

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 JAA

1–100 of 300

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