DeviceClearance

Product code KGI— Radiology

3D-SHAPER

Classification name
Densitometer, Bone
Device class
Class 2
Regulation
21 CFR 892.1170
Advisory panel
Radiology
Total cleared
148
First cleared
Most recent

Market context for product code KGI

FDA has cleared 148 devices under product code KGI between 1979 and 2026, filed by 44 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 KGI

Adverse events under product code KGI

product code KGI
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 KGI

1–100 of 148

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