DeviceClearance

Product code LMB— Radiology

7500 DATA TOWER

Classification name
Device, Digital Image Storage, Radiological
Device class
Class 1
Regulation
21 CFR 892.2010
Advisory panel
Radiology
Total cleared
55
First cleared
Most recent

FDA classification definition

“Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.”

— U.S. Food and Drug Administration, device classification record for product code LMB under 21 CFR 892.2010, via openFDA

Market context for product code LMB

FDA has cleared 55 devices under product code LMB between 1983 and 1999, filed by 42 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code LMB

Recent clearances under product code LMB

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