LMBClass I

Device, Digital Image Storage, Radiological

21 CFR 892.2010 / Radiology

LMB is the FDA product code for Device, Digital Image Storage, Radiological, a class I device type, regulated under 21 CFR 892.2010. FDA's definition for this code reads: "Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images". As of 2026-09-10, FDA records hold 55 510(k) clearances under this code, the most recent dated 1999-09-13, and 19 recalls.

Classification record

Product code: LMB
Device name: Device, Digital Image Storage, Radiological
FDA definition: Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.
Regulation: 21 CFR 892.2010
Device class: Class I
Review panel: Radiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 55
Ingested recalls: 19

Clearances, product code LMB

By decision year

55 clearances under product code LMB with a decision year between 1983 and 1999, 1996 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code LMB by decision year
Year	Clearances
1983	1
1984	1
1985	1
1986	2
1987	1
1988	2
1989	4
1990	3
1991	2
1992	3
1993	1
1994	5
1995	7
1996	10
1997	8
1998	2
1999	2

Applicants with the most clearances

Product code LMB

Applicants holding the most 510(k) clearances under product code LMB
Applicant	Clearances
Eastman Kodak Company	4
Camtronics, Ltd.	3
Eigen	3
Philips North America LLC	2
Andros Analyzers, Inc.	2
Base Ten Systems, Inc.	2
O Tech, Inc.	2
Olympus Corp.	2
Sectra-Imtec AB	2
Sony Medical Systems	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 58 companies shown, in name order