DeviceClearance

Product code JAK— Radiology

Deep Learning Image Reconstruction

Classification name
System, X-Ray, Tomography, Computed
Device class
Class 2
Regulation
21 CFR 892.1750
Advisory panel
Radiology
Total cleared
823
First cleared
Most recent

Market context for product code JAK

FDA has cleared 823 devices under product code JAK between 1976 and 2026, filed by 203 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 JAK

Adverse events under product code JAK

product code JAK
Death
27
Injury
571
Malfunction
779
Total
1,377

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 JAK

1–100 of 823

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